196 jobs found in San Diego

Parsons is seeking a Network Engineer to support a DoD contract at SPAWAR in San Diego, CA.  You will be an important member of the Defense Research and Engineering Network (DREN) Engineering team. Support the DREN Engineering team by researching, developing, documenting, testing, hardening, deploying, and integrating next generation network, systems, and network-based security solutions as well as providing tier 3 technical support to operations.    Work closely with customer to define and track requirements, develop a schedule and provide project updates, obtain resources and ensure tasks are completed to customer’s satisfaction. Collaborate and coordinate with other engineering, operations, and security personnel to determine new or updated capabilities and services and to develop the concept of operations (CONOPS) for the operationalized solution. Work closely with vendors to install, configure and maintain equipment in a lab environment to support capability development or reproduce and find bug fixes or mitigations. Ensure that developed solutions are configured to meet security guidelines by reviewing and providing STIG checklists, ACAS scans, NIPPER reports and other accreditation artifacts to security team. Write and edit Methods of Procedures (MOPs) and Standard Operating Procedures (SOPs) describing the configuration, deployment, field test, transition, and operation of developed solutions.   Solutions to be developed may include but are not limited to: Routing, Switching, SDN, NFV. Multi-Tenant and Cloud platforms. Network-based Security Monitoring and Protections such as Sensing, Firewall, IDS/IPS, Distributed Denial of Service (DDoS), Web Content Filter, Proxy, Full Packet Capture, Insider Threat, Event Correlation, DNS RPZ   Qualifications: DoD 8570 certification (Network+ or Security+) Bachelor's Degree in a information technology or related field 2+ years of experience TCP/IP, BGP, DNS, SSL, IPv6 VLAN, Virtual Routers, Layer 2 and Layer 3 VPN Network Documentation (Visio), Protocol Analysis (Wireshark) Security Assessment (ACAS, NIPPER) AN ACTIVE DOD SECRET CLEARANCE OR HIGHER   Preferred: Virtual machines (VM), Windows or Linux systems proficiency Scripting CISSP     Must be able to obtain, maintain and/or currently possess a security clearance.   Ready for action? We’re looking for the kind of people who see this opportunity and don’t hesitate to act. Parsons is a leader in the world of Technical Services and Engineering. We hire people with a broad set of technical skills who have proven experience tackling some of the greatest challenges. Take your next step and apply today.

Position Summary: Illumina is looking for a highly motivated, energetic individual that is creative and strategic with a drive to deliver results in a fast-paced innovative space. This attorney joins a dynamic legal team and will be the legal advisor and strategist for product development projects and related portfolios.  Responsibilities include capturing inventions, building enforceable global patent portfolios as well as setting and advising on IP strategy to create long term business value.  Location will be Illumina’s San Diego Headquarters.     All About You   Responsibilities: Prepares and prosecutes global patent applications. Develops and executes against a forward looking IP strategy for projects and portfolios in line with company business goals.  Collaborates within and across business units to identify and capture high value innovation.  Cost-effectively manages high quality patent prosecution work by outside counsel in the US and abroad. Effectively partners with product development teams to shape IP strategy for product offering.  Provides value/risk assessment on third party IP estates and/or landscapes for collaborations, consortiums and other third party complex agreements. Contributes to intellectual property assessments in mergers, acquisitions and investments. Works strategically and collaboratively with IP litigation team. Contributes to educational efforts across business on best practices for IP and other legal matters. Drives operational excellence within legal and across the business.   All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.     Requirements: 4+ years of patent prosecution experience required. Top tier law firm and in-house experience strongly preferred. Demonstrated strong strategic and analytical thinking. Experience with global patent prosecution, patent appeals, re-examination, re-issue, inter partes reviews proceedings, and litigation is a plus.  Proven track record as team player with strong work ethic. Clear and flexible communication skills. Able to adapt and iterate seamlessly in a fast-paced environment. Approaches life with a ‘can do’ attitude. Exemplifies highest ethical standards.   Education: Technical degree required in chemistry, life sciences, biotechnology, material sciences, or related field. Advanced technical degree (Masters or Doctorate) in the above disciplines strongly preferred. U.S. Law degree and license required. USPTO Registration Number required. Knowledge of genetics and other biological sciences is beneficial.     Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

Position Summary Illumina is expanding its reach into the clinical market with its innovative next generation sequencing platforms and assays. We are seeking a talented Senior Manager, Alliances to manage key pharmaceutical and/or in vitro diagnostic development and commercialization partnerships that are critical to expanding the test offerings and applications on Illumina platforms. The Senior Manager, Alliances will be responsible for managing the partnership lifecycle, including the formation and leadership of implementation team, creation of joint working team and governance structure, maintenance and growth of strategic alignment, overall partnership health, and expansion of transformative business opportunities.    Key Tasks and Responsibilities Manages all aspects of the alliance lifecycle, including strategic and day-to-day operating activities with assigned partners Forms and leads implementation teams while working internally with key stakeholders to meet milestones and deliverables according to the partnership agreement Plans and coordinates contractual implementation activities between the internal project team and external partner stakeholders Administers the governance structure of the relationship Assesses alliance health and works to strengthen individual and organizational relationships between the companies Serves as the primary point of communication for partners and facilitates efficient and effective communication with the partner Ensures partner needs are communicated internally and addressed appropriately Identifies areas of discordant expectations between organizations and works to resolve them Escalates internal or external issues that could damage partnership health or cause a missed milestone/deliverable to ensure resolution Seeks to understand cultural similarities and differences between organizations and uses the knowledge to improve working mechanisms between teams Monitors results against key performance indicators and communicates results internally Negotiates statements of work and associated budgets and timelines Identifies opportunities to generate new or unforeseen value from a partnership Works with manager to develop and improve processes related to the alliance management function Disseminates key learnings and best practices to foster continuous improvement in Illumina’s partnering capabilities      Education and Experience 7-10+ years experience in alliance management, project management, business development, or other related experience with significant partnering responsibilities 5+ years experience in pharmaceuticals, diagnostics, and/or CROs Bachelor’s degree in business, life sciences, or a related field is required; advanced degree and/or MBA is preferred Alliance management certification, such as CA-AM or CSAP is preferred Preference for candidates with familiarity in oncology, in vitro diagnostics, clinical trials, and/or companion diagnostic regulatory pathways   Requirements Has strong listening and speaking skills, as well as the ability to communicate at all levels of an organization internally and externally Thrives in a collaborative work environment, where interacting effectively with peers, functional managers and senior leadership will drive success Can align needs of internal and external stakeholders to create winning situations for all parties Has a demonstrated ability to think critically and strategically about partnerships Incorporates highly effective organizational skills and planning ability into alliance work Effectively champions partners’ needs and can maintain steady engagement in the partnership’s objectives over multiple years Is willing to travel up to 30% of time  All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.     Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply Posted 30+ Days Ago Full time 19029-JOB About Us   Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives.   We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.        

We are looking for a driven Leader of GQO Business Development (BD) Partnerships to lead the Global Quality and Operations (GQO) strategy and deliverables for BD Partnerships.  The role will report directly to the leader of the Process Development and Transfer (PDT) group and represent the needs of the GQO team in the development of new business deals, contract negotiation, and execution of the deals.   This individual will be accountable for the following major deliverables:   Accountable for GQO Partnership strategy Drive GQO Business Development deliverables and contract reviews Provide Program Management oversight of active deals and deals in the funnel to GQO leadership Define, resource, and manage specific GQO partnership deliverables Define and drive specific pro-active GQO process infrastructure and improvements portfolio to meet current and future Partnership needs Effectively partner across all of the Illumina organization   This position shapes the future of the GQO organizational response to company partnership strategy.   The ideal candidate will have strong experience in Operations including manufacturing, supply chain, quality, contract negotiation and process improvement.    Responsibilities: Accountable for GQO Partnership strategy including GQO infrastructure improvements and close collaboration with Business Development and Marketing to meet partnership needs Translate Partnership strategy & deal action into GQO deliverables and ensures timely completion Serves a GQO Liaison for BD Engages early in customer negotiations and ensures GQO is represented Program manages the active and new deals across consumables and instruments to ensure portfolio of commitments are met proactively Reports out regularly to GQO leadership on strategy, deals, progress, and goals. Ensures projects secure the GQO resources and funding as needed Accountable for driving the pro-active process improvement portfolio to meet current and future Partnership needs across GQO Scope includes all end to end GQO processes and infrastructure Partners across all Illumina functions as the GQO Liaison for Partnership improvements Drives cross functional prioritization and decision making across the GQO improvement portfolio to enable Partnerships   Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.   Education: B.S./M.S./PhD in Chemical Engineering, Biochemical Engineering, Biotechnical Engineering, or MS/PhD in Materials Science or Physical Chemistry At least 10-15 years of relevant experience and at least 5 years as a technical and strategic manager.       Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply  

Position summary:   This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for driving change, establishing sustainable processes, improving products, and providing senior management with actionable process and product data. The position requires exceptional communication, interpersonal and project management skills to effectively coordinate activities and deliver results.  A solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD) is required.   This position will have direct interaction with Manufacturing operations and Process Engineering  groups to support manufacturing sustaining activities, continuous improvement and manufacturing capacity expansion. The position may also have responsibility for new product introduction (NPI) quality oversight for more than one manufacturing area. The position will be responsible to lead risk management activities and support development of process/product validation strategies during technology transfer of new product to the sustaining team. This position will also participate in the sharing of best practices and lessons learned from NPI and Sustaining Quality.   Responsibilities: Provide quality leadership to capacity expansion and new product development teams in the areas of design process control, design process verification and validation, design transfer, process validation, risk management, and specification development. Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements. Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions. Aides in the assessment and qualification of new supplier materials such as component specifications and inspection standards. Drive product process risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders. Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports. Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making. Review verification and validation reports and identify gaps for GMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner. Coordinate issue resolution using a risk-based approach. Ensure product development manufacturing processes and validation programs meet requirements of FDA and ISO. Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis. Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion. Collaborate with the procurement, purchasing, and product design groups to assure compliance/quality of new vendors/materials. Other activities as assigned.   Requirements: A minimum of 5 to 6 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic development and/or manufacturing. Strong communication, facilitation, planning, problem-solving and organizational skills. Demonstrated effective project management skills and collaboration on teams in multiple/global locations is desired. Demonstrated ability to, or aptitude to learn how to, manage and lead change. Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact. Experience with quality and process improvement methodologies and tools. Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands. Ability to execute strategy, approach, methods and actions on new assignments. Is considered a subject matter expert for assessing and resolving complex quality issues. Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR). Effective data mining, trend analysis, statistical analysis. Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES). Experience with enterprise Quality System tools (e.g., electronic CAPA, Complaint Management systems). Background in chemistry, biochemistry or a related engineering discipline is preferred. Background in oligonucleotide synthesis and surface activation chemistry a plus. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.  Changes to individual responsibilities may occur due to business needs.   Experience/Education: Bachelor’s degree in an engineering or scientific discipline. Graduate degree in an engineering or scientific discipline and/or business is preferred. Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CQA, RAC).       Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

Responsibilities: Design creative solutions for desktop, web, & mobile applications using modern design methods in a variety of product development methodologies including Agile frameworks and Phase-Gate approaches  Develop high level and detailed storyboards, wireframes, mock-ups, and prototypes to effectively communicate design concepts  Collaborate with Product Management, and Engineering to understand and incorporate business and technical requirements in design strategies  Collaborate with technical leads to negotiate design requirements and play an active role in design iterations  Partner with User Researchers on user testing activities to understand design and usability issues and propose changes to solve them  Manage large projects, overseeing the activities of other interaction and visual designers, and researchers, to ensure delivery of products that meet business objectives and delight customers. Be a strong driver of user centered design processes, ensuring that these processes are foundational to all the projects you oversee.  Be able to balance user needs and business objectives as you develop products, possessing the acumen and flexibility to gain alignment with large teams, making adjustments when needed.   All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.   Requirements: Masters in Human Computer Interaction, Industrial Design, Human Factors or other design-related field is preferred  10 + years of experience in Interaction Design with emphasis on desktop, web, and mobile product design  Excellent knowledge of all aspects of user centered design process, methodology, and UI design best practices  Excellent analytical ability, especially with regard to understanding user behavior and design theories  Advanced experience with design and prototyping tools such as Sketch, Invision, and the Adobe Creative Suite  Demonstrated experience with turning customer insight into interaction designs  A proven track record of working well with multi-disciplinary/multi-cultural teams  Knowledge of the software development process and ability to communicate well with software development teams  Ability to know when to leverage existing design patterns and when an innovative approach to a design problem is called for. Ability to embrace collaboration with all team members, including product, project, and development team members as well as UX colleagues. Background in scientific, healthcare, or enterprise B2B is a plus.   Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.  Changes to individual responsibilities may occur due to business needs.       Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

STAFF GLOBAL TRADE ANALYST   Position Summary: The Staff Global Trade Analyst will serve as a critical resource on the Global Trade Compliance team for cross-functional project implementation, as well as projects within the Global Trade function. Strong cross-functional collaboration, ability to influence across the organization as well as possession of outstanding analytical skills are required.  This role is responsible to provide technical knowledge of the Trade functions, SAP and GTS in order to perform impact analysis, tradeoff analysis and global trade requirements for customer service, supplier management and supply chain strategic initiatives.  The candidate should possess an in-depth knowledge of Trade Operations, Customs valuation concepts, Order to Cash functions, SAP master data and transactional data, finance and product introduction insight.   Responsibilities: Define, justify, and prioritize new initiatives and opportunities, recommend next steps and project follow up, as needed Work with the Global trade compliance, tax, logistics and GIS functions to gather, understand, and define global trade business requirements for cross-functional projects. Collaborate with cross-functional stakeholders to drive continuous improvement initiatives that increase compliance with Global Trade regulations Collaborate with GIS and business teams to support design of trade compliant application solutions by analyzing functional requirements, determining trade impact, and recommending options, by creatively leveraging standard SAP and GTS capabilities. Review user stories to-be process flows and scope of cross-functional projects to ensure that trade compliance requirements are met at each phase of the project. Lead cross-functional team members in the implementation of Global Trade strategic projects and enhancements from requirements gathering through deployment and post-production support Manage multiple priorities and stakeholder expectations Drive projects, deliverables, critical issues, and action items to on-time completion Maintain active communication with stakeholders to manage expectations regarding changes to the system and the introduction of new and enhanced functionality Play an active role in operational readiness testing for application systems, performing hands-on testing and coordinating UAT Assess and communicate change impacts prior to change deployment   Requirements: Experience in Global Trade operations, import / export functions, international logistics or international sales Experience with Global Trade regulations for biotech consumables, medical devices and/or drugs and various other government agencies (FDA, APHIS, etc) preferred. Experience with a Global Trade Management Solution, preferably SAP GTS Experience with SAP ECC functions Experience working in “best in class” operations organizations preferred Excellent written, presentation, and communications skills Advanced level of experience with analytics supporting systems, MS Excel, PowerPoint, Visio, MS Project Knowledge and working application of risk analysis and standard operating procedures Ability to identify and resolve complex problems in relation to Global Trade & International Logistics activities Ability to be influential and credible with Sales, Tax, Finance, Customer Support, Purchasing Distribution, Logistics and Supply Chain staff, and other internal stakeholders Ability to influence and work with a diverse indirect team in a fast-paced environment Team oriented, collaborative partner that passionately advocates and articulates their opinion while maintaining flexibility to incorporate others point of views Demonstrated ability to accomplish goals by working and influencing across departments Good interdepartmental communication skills and documentation skills Demonstrated ability to manage and drive multiple projects and priorities Experience in driving efficiency via reporting and/or application of KPIs/metrics Self-motivated and proactive   Experience/Education: Requires a minimum of 6-8 years of related experience with a Bachelor’s degree; or 1-3 years with a Master’s degree; or a PhD without experience; or equivalent work experience         Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

STAFF GLOBAL TRADE ANALYST   Position Summary: The Staff Global Trade Analyst will serve as a critical resource on the Global Trade Compliance team for cross-functional project implementation, as well as projects within the Global Trade function. Strong cross-functional collaboration, ability to influence across the organization as well as possession of outstanding analytical skills are required.  This role is responsible to provide technical knowledge of the Trade functions, SAP and GTS in order to perform impact analysis, tradeoff analysis and global trade requirements for customer service, supplier management and supply chain strategic initiatives.  The candidate should possess an in-depth knowledge of Trade Operations, Customs valuation concepts, Order to Cash functions, SAP master data and transactional data, finance and product introduction insight.   Responsibilities: Define, justify, and prioritize new initiatives and opportunities, recommend next steps and project follow up, as needed Work with the Global trade compliance, tax, logistics and GIS functions to gather, understand, and define global trade business requirements for cross-functional projects. Collaborate with cross-functional stakeholders to drive continuous improvement initiatives that increase compliance with Global Trade regulations Collaborate with GIS and business teams to support design of trade compliant application solutions by analyzing functional requirements, determining trade impact, and recommending options, by creatively leveraging standard SAP and GTS capabilities. Review user stories to-be process flows and scope of cross-functional projects to ensure that trade compliance requirements are met at each phase of the project. Lead cross-functional team members in the implementation of Global Trade strategic projects and enhancements from requirements gathering through deployment and post-production support Manage multiple priorities and stakeholder expectations Drive projects, deliverables, critical issues, and action items to on-time completion Maintain active communication with stakeholders to manage expectations regarding changes to the system and the introduction of new and enhanced functionality Play an active role in operational readiness testing for application systems, performing hands-on testing and coordinating UAT Assess and communicate change impacts prior to change deployment   Requirements: Experience in Global Trade operations, import / export functions, international logistics or international sales Experience with Global Trade regulations for biotech consumables, medical devices and/or drugs and various other government agencies (FDA, APHIS, etc) preferred. Experience with a Global Trade Management Solution, preferably SAP GTS Experience with SAP ECC functions Experience working in “best in class” operations organizations preferred Excellent written, presentation, and communications skills Advanced level of experience with analytics supporting systems, MS Excel, PowerPoint, Visio, MS Project Knowledge and working application of risk analysis and standard operating procedures Ability to identify and resolve complex problems in relation to Global Trade & International Logistics activities Ability to be influential and credible with Sales, Tax, Finance, Customer Support, Purchasing Distribution, Logistics and Supply Chain staff, and other internal stakeholders Ability to influence and work with a diverse indirect team in a fast-paced environment Team oriented, collaborative partner that passionately advocates and articulates their opinion while maintaining flexibility to incorporate others point of views Demonstrated ability to accomplish goals by working and influencing across departments Good interdepartmental communication skills and documentation skills Demonstrated ability to manage and drive multiple projects and priorities Experience in driving efficiency via reporting and/or application of KPIs/metrics Self-motivated and proactive   Experience/Education: Requires a minimum of 6-8 years of related experience with a Bachelor’s degree; or 1-3 years with a Master’s degree; or a PhD without experience; or equivalent work experience         Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

Position Summary The position will be part of the Platform Services and Applications team. The selected candidate's responsibilities include supporting data integration and analytics applications, requirements gathering and analysis, planning and coordination, as well as software installation, configuration, testing, and documentation. Responsibilities also include ensuring high levels of service quality, availability, and solving complex technical problems.   Responsibilities Translate business requirements into solution design. Work with specifications to design, implement, and maintain high availability application services to provide users with the tools and data needed to do their jobs more effectively Install, configure, and support enterprise applications Develop, update, and implement policies and procedures to maintain best practices across the team's portfolio Setup and configure process and system monitors to track service availability and performance Service capacity and performance management Independently debug and resolve complex application issues and problems Develop and update scripts used to automate tasks and processes Provide after-hours on-call support on a rotating basis ​ Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.     Requirements 7+ years of experience with BI application administration and management 7+ years of experience administering and supporting web and application servers including Apache, Tomcat, and IIS 5+ years of experience administering and supporting IBM Cognos Analytics 5+ years of experience administering and supporting Tableau Server 3+ years of experience administering and supporting job scheduling systems such as BMC Control-M 7+ years of experience administering and working on Linux and Windows Server operating systems 5+ years of experience with scripting languages such as Shell, Power Shell, and Python 3+ years of experience working with relational databases such as Microsoft SQL Server, SAP HANA, AWS Redshift, and MySQL Experience with Informatica IICS, Denodo, IBM Planning Analytics, and SQL a plus Experience working with and running services on AWS including EC2 and storage solutions Strong understanding of the Software Development Life Cycle including BI report development Experience working in regulated industries with FDA and SEC related change management processes a plus Excellent oral and written communication skills Strong  teamwork and problem solving abilities     Education B.S. in Computer Science or equivalent degree     Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply  

In this Senior Platform Management Team (PMT) Design Quality Engineer role, you will be a quality engineer in one or more on-market product management teams expected to support activities with the team to assess, evaluate, and implement changes to product (RUO and IVD) and/or manufacturing processes driven from complaints, non-conformances, CAPA’s, product risk management, and other internal or market driven data.  This role requires exceptionally enthusiastic communication and interpersonal skills, and proven successes in navigating the intent of FDA and ISO 13485 standards- most specifically areas pertaining to Design Control, Process Control, Risk Management (ISO 14971), and Post Market Surveillance. Responsibilities: Support of change management activities for on-market Illumina products Accountable for: Guiding impact assessments for design, process, and risk control activities as required Review engineering reports for accuracy and presence of sufficient data to support each change Review and approval of all required change deliverables Documentation of the proposed changes and maintenance of the quality documentation Accountable for: Maintaining and updating documentation within product Design History Files Support and update of BOMs to ensure proper capture of design changes and criticality flag updates Preparation of story boards and documentation for audits Support of Risk Management activities for on-market products Accountable for: Performing Product Risk Management File updates and reviews, as required Facilitate Risk Assessments on new risks as required Providing feedback into new product development as required Support of Root Cause Analysis activities for on-market products Accountable for: Collaboration with teams to apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving product quality issues Assists in detecting trends/recurring issues in data; and reports on analysis, makes recommendations Provide management with status updates on assigned responsibilities and goals- escalating issues and proposing solutions as necessary. Take initiative to identify and implement improvements to the Illumina quality system.   Requirements: •5-8+ years’ experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic or Medical Device development and/or manufacturing preferred. • Demonstrated knowledge and capability in data analytics methodologies and tools preferred (JMP, R, Minitab, Tableau, SAS, etc.). • Practical experience in design controls, risk management, process controls, change management, and post market surveillance. • Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, IVDD). • Experience with 8D, CAPA, 6M and other failure investigation tools and techniques. • Applied experience with quality and statistical analysis tools (e.g. Top Down & Bottom Up Risk Analysis, DOE, and trend analysis). • Highly effective communication, facilitation, coaching, and negotiation skills. • Adaptable to fast-paced, dynamic work environment with shifting demands. • Demonstrated ability to accomplish goals while working across departments is required. Education: Bachelor’s of engineering degree in Chemical, Biochemical, or related discipline.       Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

This individual will be responsible for validation deliverables for the instrument NPI team. This role requires preferably a background in an engineering discipline in Mechanical, Bioengineering, Chemical or relevant instrumentation work with a science background in chemistry, biology or related field. This position requires knowledge of process validation principals, manufacturing controls, problem solving skills and application for Medical device standard requirements. This engineer will collaborate with a multi-discipline global team that includes development, engineering, software, quality and manufacturing teams. As needed, this engineer will also support product/process improvement projects that require validation support.   We are looking for a driven, talented Senior Validation Engineer to join our growing Validation Engineering Team. The Validation Engineering Team works as an integral part of our Instrument Manufacturing process supporting new product introduction, sustaining manufacturing, and supporting projects that increase quality and yield within our production environments.   This individual will work in a dynamic team-oriented environment and has primary responsibility for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining validation deliverables/activities for manufacturing processes, Software and equipment.      Responsibilities: Coordinate with end users and process owners to lead development of validation strategy for projects, systems, and processes. These projects may span sustaining manufacturing, the introduction of new manufacturing processes and systems, and/or manufacturing improvements. Manage individual validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports.   Software/System Implementation and Validation: Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software. Assist with development and review of system/software requirements to ensure testability. Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts. Perform statistical analysis related to process validation Develop and execute IQ, OQ and PQ protocols for manufacturing processes, systems, and test equipment. Write reports summarizing results and statistics for all equipment, product, or process validation projects. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures. Provide day-to-day support to development, engineering, and manufacturing teams for design control planning and design transfer activities. Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports.  Learn and understand the applicable technology and engage in technical discussions. Identify areas and opportunities to improve manufacturing facilities, processes, and equipment. Partner cross-functionally with Development, Quality, Manufacturing and other engineering groups to develop processes for new products and sustain and improve processes for existing products. Participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing, and system level testing with new software Provide consultation to other departments performing validation activities Ensure validation program meets requirements applicable medical device standards   Requirements & Education: Bachelor’s degree in engineering, science, or related field required and a minimum of 3 years of related experience.  Experience in the biotech, medical device/IVD industry in the development and deployment of Manufacturing processes, process controls, and continuous improvement methods. 3-5 years of Manufacturing, Quality Engineering, and/or engineering experience in an FDA regulated environment is strongly preferred. Knowledge and working application of FDA, ISO 13485 and cGMP requirements. Knowledge and working application of Validation Principles and guidelines and industry practice, FMEA, and Risk Analysis. Knowledge and working application of standard operating procedures. Demonstrated ability to accomplish goals while working across departments is required. Demonstrated strong analytical problem solving ,team collaboration, and communications/interpersonal skills. Computer competency in MS Office. Excellent interpersonal, written, and verbal communication skills. Adaptable to fast-paced, dynamic work environment with ability methodically manage projects.    Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.           Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply  

This individual will be responsible for validation deliverables for the instrument NPI team. This role requires preferably a background in an engineering discipline in Mechanical, Bioengineering, Chemical or relevant instrumentation work with a science background in chemistry, biology or related field. This position requires knowledge of process validation principals, manufacturing controls, problem solving skills and application for Medical device standard requirements. This engineer will collaborate with a multi-discipline global team that includes development, engineering, software, quality and manufacturing teams. As needed, this engineer will also support product/process improvement projects that require validation support.   We are looking for a driven, talented Senior Validation Engineer to join our growing Validation Engineering Team. The Validation Engineering Team works as an integral part of our Instrument Manufacturing process supporting new product introduction, sustaining manufacturing, and supporting projects that increase quality and yield within our production environments.   This individual will work in a dynamic team-oriented environment and has primary responsibility for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining validation deliverables/activities for manufacturing processes, Software and equipment.      Responsibilities: Coordinate with end users and process owners to lead development of validation strategy for projects, systems, and processes. These projects may span sustaining manufacturing, the introduction of new manufacturing processes and systems, and/or manufacturing improvements. Manage individual validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports.   Software/System Implementation and Validation: Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software. Assist with development and review of system/software requirements to ensure testability. Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts. Perform statistical analysis related to process validation Develop and execute IQ, OQ and PQ protocols for manufacturing processes, systems, and test equipment. Write reports summarizing results and statistics for all equipment, product, or process validation projects. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures. Provide day-to-day support to development, engineering, and manufacturing teams for design control planning and design transfer activities. Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports.  Learn and understand the applicable technology and engage in technical discussions. Identify areas and opportunities to improve manufacturing facilities, processes, and equipment. Partner cross-functionally with Development, Quality, Manufacturing and other engineering groups to develop processes for new products and sustain and improve processes for existing products. Participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing, and system level testing with new software Provide consultation to other departments performing validation activities Ensure validation program meets requirements applicable medical device standards   Requirements & Education: Bachelor’s degree in engineering, science, or related field required and a minimum of 3 years of related experience.  Experience in the biotech, medical device/IVD industry in the development and deployment of Manufacturing processes, process controls, and continuous improvement methods. 3-5 years of Manufacturing, Quality Engineering, and/or engineering experience in an FDA regulated environment is strongly preferred. Knowledge and working application of FDA, ISO 13485 and cGMP requirements. Knowledge and working application of Validation Principles and guidelines and industry practice, FMEA, and Risk Analysis. Knowledge and working application of standard operating procedures. Demonstrated ability to accomplish goals while working across departments is required. Demonstrated strong analytical problem solving ,team collaboration, and communications/interpersonal skills. Computer competency in MS Office. Excellent interpersonal, written, and verbal communication skills. Adaptable to fast-paced, dynamic work environment with ability methodically manage projects.    Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.           Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply  

Responsibilities: Plan and execute various laboratory activities with limited instruction Recognize potential problems, understand and troubleshoot assays and work to resolve any issues to minimize impact on success of project. Optimize complex assays to achieve commercial levels of stability and performance. Help plan and execute verification and validation studies. Report recommendations based on tested experimental results. ·Assesses information to ensure data sufficiency and completeness of results. Write experimental protocols and reports Write experimental summaries and prepare technical presentations for updating supervisor and other team members as appropriate. Provide verbal progress reports in both formal and informal settings Interface with various departments. Act as a key contributor within integrated and multidisciplinary teams developing new assays, and improving existing assays. Assesses information to ensure data sufficiency and completeness of results. Write experimental reports, summaries and protocols for supervisors, project needs, and other teams as appropriate Use standard laboratory instrumentation: i.e. UV-VIS, fluorescence plate readers, thermocyclers, liquid handling robotics Perform other duties as needed.   Requirements: Good knowledge of standard molecular biology/nucleic acid-based protocols for both DNA and RNA Experience in IVD product development highly desirable. Solid understanding of scientific principles. Sound laboratory skills required. Experience developing workflows for microfluidic systems or liquid handling robots (e.g., Hamilton, Tecan, Eppendorf)Ability to work independently as well as in a team setting Detail-oriented, organized, ability to implement protocols and keep good notes in a lab notebook. Excellent communication skills, both written and verbal A desire to be part of fast paced dynamic development environment.   Experience/Education: Typically requires a Bachelor’s degree in Molecular Biology, Biochemistry, Genetics or related field and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.     Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

Responsibilities Coordinate across multi-disciplinary teams to transform user needs into a complete description of software system requirements Lead use case development, requirements gathering, requirements analysis and review meetings Create wireframes, high-quality workflow and process-flow diagrams, and other visualizations to communicate technical concepts Write formal, detailed software requirements specifications and software design documentation Manage requirements priority, changes, and planning for future product versions in a scalable and sustainable design Work in a collaborative team environment; accurately and fully describe user needs to UX, software/firmware development, and testing team members Support overall project management such as sprint and release planning Work closely with software/firmware test teams to assist in troubleshooting system issues, and drive system design improvements Research, analyze and design complex information systems and technology solutions in support of user/business needs. Provide technical expertise in identifying, evaluating and developing procedures that are cost effective and meets user/business needs.   Skills & Experience Bachelor’s degree or higher in Computer Science, Biomedical Engineering or related discipline 3-5 years in software systems analysis Knowledge of formalized requirements gathering and analysis methods and tools Strong written and verbal communication, and presentation skills, for both technical and non-technical audience Experience with Software Development Life Cycle and Scrum methodologies Ability to multi-task, stay organized, and incorporate feedback in a fast-paced environment Experience with Atlassian tools (Jama, Jira, Confluence) and prototyping tools (Balsamiq, Axure), a plus. Experience with Next Generation Sequencing and Data Analysis, a plus Experience with design/development/testing/support of software/firmware applications for biomedical instruments/ medical devices, a plus       Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

As a senior fluidics engineer at Illumina, you will work in a dynamic, team-oriented environment and help create genomic analysis tools that enable leading-edge research. You will be an individual contributor within multidisciplinary teams developing new, and improving existing, technology platforms. Primary responsibilities include the design and characterization of fluidic components and parameters, in both instrument and consumables, and the development / execution of critical parameter studies to drive high reliability and robustness. This candidate should possess strong organizational and communication skills to facilitate successful product development across hardware, consumable, chemistry, firmware, and software teams.   Job Activities: Assist in the design of fluidic sub-systems using continuous flow-based (i.e. pressure-driven) and the design of custom components and protocols. Conduct analyses including flow parameter characterization and tolerance analyses to drive specifications of fluidic components and protocols. Setup, plan and execute experimental evaluations (i.e. DOEs) and author test plans to verify critical specifications in fluidic subsystems. Design and fabricate test stands for the characterization and life testing of fluidic sub-systems. Troubleshoot fluidic sub-systems in all phases of product development. Work independently and within multi-disciplinarily project teams with engineers, programmers, project coordinators, and other researchers. Be a self-starter, analytically oriented, with a hands-on approach to design, testing and troubleshooting. Conduct clear and concise communication with colleagues and supervisors through oral updates, written reports and technical meetings.   All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.   Education: Ph.D. in in Mechanical Engineering, Bioengineering or related field with 1-2 years of industry experience. M.Sc. in Mechanical Engineering, Bioengineering or related field with 3-5 years of industry experience.   Requirements: Knowledge of basic fluid dynamics and principles. Experience with experimental design and execution, including DOEs and root cause analysis. Experience with programming languages (MATLAB, LabView, C++, etc…). Proven skills in analysis of large complex data sets helpful. Experience in microbiology or biochemistry labs preferred. Demonstrated ability to work independently and collaboratively across disciplines. Excellent communication skills required.     Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply  

Position Summary: We are looking for a highly talented senior engineer to be a part of the Metrology and Physical Systems team within the product development engineering group. A candidate with facility in statistical methods, data analysis and programming/scripting languages would be considered. As a successful candidate you will work in a fast pace multidisciplinary environment to create consumable devices to enable next generation sequencing products.   All About You   Responsibilities: Apply statistical methods to design experiments, analyze and interpret data Develop first principles models for Illumina products and processes Developing novel metrology tools and/or model systems for critical parameter analysis Manage databases of process and metrology data. Mine process and metrology data as part of post-hoc root cause analysis Strong communication skills with the ability to work on multi-disciplinary teams in a fast-paced environment are required.    Requirements: Ph.D. with 0 to 3 years of experience or BS/MS with 2+ years of experience Fluency with one or more of the following programming environments: R, Python, C, C++, C#, Matlab, LabView Experience with image processing is a plus Knowledge of Arduino, RaspberryPi or similar microcontrollers is a plus Self-driven team player with attention to detail and analytical problem-solving skills, that can work well in a fast-paced multi-disciplinary industrial environment.   Education: The ideal candidate will have a degree in Science or Engineering, Physics, Electrical Engineering, Biomedical Engineering or related discipline     Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply

Position summary:   This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for driving change, establishing sustainable processes, improving products, and providing senior management with actionable process and product data. The position requires exceptional communication, interpersonal and project management skills to effectively coordinate activities and deliver results.  A solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD) is required.   This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement and manufacturing capacity expansion. The position may also have responsibility for new product introduction (NPI) quality oversight for more than one manufacturing area. The position will be responsible to lead risk management activities and support development of process/product validation strategies during technology transfer of new product to the sustaining team. This position will also participate in the sharing of best practices and lessons learned from NPI and Sustaining Quality.   Responsibilities: Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development Provide ongoing quality engineering support throughout the product life cycle Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions Ensure manufacturing processes and validation programs meet requirements of FDA and ISO. Aides in the assessment and qualification of new supplier materials such as component specifications and inspection standards Provide quality leadership to capacity expansion and new product development teams in the areas of process control, process verification and validation, design transfer, risk management, and specification development. Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements. Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making Review verification and validation reports and identify gaps for GMP compliance Develop and execute strategies to close gaps in an efficient, technical, and compliant manner Coordinate issue resolution using a risk-based approach Identify areas and opportunities to improve quality system processes Ensure product development and validation programs meet requirements of FDA and ISO Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion Supports department's SCARs Track and trend supplier performance and recommend appropriate actions Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis. Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion. Collaborate with the procurement, purchasing, and product design groups to assure compliance/quality of new vendors/materials. Collaborate with counterparts and cross-functional teams at other Illumina sites. Other activities as assigned   Requirements: A minimum of 5 to 6 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic development and/or manufacturing. Strong communication, facilitation, planning, problem-solving and organizational skills. Demonstrated effective project management skills and collaboration on teams in multiple/global locations is desired. Demonstrated ability  or aptitude to learn how to manage and lead change. Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact. Experience with quality and process improvement methodologies and tools. Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands. Ability to execute strategy, approach, methods and actions on new assignments. Is considered a subject matter expert for assessing and resolving complex quality issues. Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR). Effective data mining, trend analysis, statistical analysis. Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES). Experience with enterprise Quality System tools (e.g., electronic CAPA, Complaint Management systems). Background in chemistry, biochemistry or a related engineering discipline is preferred. Background in oligonucleotide synthesis and surface activation chemistry a plus. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.  Changes to individual responsibilities may occur due to business needs.   Education: Bachelor’s degree in an engineering or scientific discipline. Graduate degree in an engineering or scientific discipline and/or business is preferred. Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CQA, RAC).       Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply Posted 30+ Days Ago Full time 19290-JOB About Us   Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives.   We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina. Similar Jobs Sr MFG/OPS Quality Engineer | US - California - San Diego      

We are looking for a driven, talented Process Engineer / Scientist  to join our growing Manufacturing Technical Operations (MTO) group. The MTO group works as an integral part of our Consumables Manufacturing process and is tasked with increasing quality and yield within our production environments. This individual will provide technical support to new product introduction, production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products.   Responsibilities: Provide technical leadership in the production and analysis of nucleotides, modified triphosphates, and/or oligonucleotides, in a regulated manufacturing environment. Collaborate with cross-functional teams to both (1) address operational sustaining needs (i.e. resolve production issues related to safety, yield, quality, and/or throughput) and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products Represents Operations’ needs in cross-functional meetings to ensure quality, continuity and efficiency of products and processes transferred to and implemented within manufacturing teams. Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements. Analyze, trends, monitors and updates Manufacturing KPIs and metrics. Support non-conformances/CAPA’s through providing technical evaluations and investigations. Support continuous improvement and sustaining activities. Aid in the selection of appropriate components and vendors in area of responsibility. Support the transfer of manufacturing processes between manufacturing locations. Facilitate productive cross-site and cross-functional relationship between manufacturing sites. Able to plan and prioritize assigned tasks and activities with minimal guidance. Execution of tasks with guidance from project lead or manager. Provides technical decisions in own area of responsibility. Tracks component COGS and associated project expenses   Requirements: Demonstrated ability to make oligonucleotides, nucleotides, and/or associated subassemblies Manufacturing experience of organic synthesis is highly desirable Working knowledge and experience of automated synthesis, preparative and analytical chromatography.  LC-MS and ability to interpret NMR is desirable. Experience in process support and development in a GMP environment Strong analytical, problem solving, troubleshooting, and root cause analysis skills Strong interpersonal, verbal and written communication skills required Must be detail oriented Strong understanding of GMP Experience with standard laboratory practices Strong computer skills are required. Programming knowledge is a plus. Experience with SAP or equivalent ERP system Experience working in an ISO 13485 or FDA regulated environment is desirable Experience with lean manufacturing tools and principles is a plus Experience with statistics, Statistical Process Control and DOE techniques is desirable   Education: MS Degree in Organic Chemistry, Chemistry, Molecular Biology/Biochemistry, Chemical Engineering, Biochemical Engineering or similar discipline with 1+ years of related experience BS Degree in Organic Chemistry, Chemistry, Molecular Biology/Biochemistry, Chemical Engineering, Biochemical Engineering or similar discipline with 3+ years of related experience   Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.  Changes to individual responsibilities may occur due to business needs.     Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply  

We are looking for a driven, talented Process Engineer / Scientist  to join our growing Manufacturing Technical Operations (MTO) group. The MTO group works as an integral part of our Consumables Manufacturing process and is tasked with increasing quality and yield within our production environments. This individual will provide technical support to new product introduction, production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products.   Responsibilities: Provide technical leadership in the production and analysis of nucleotides, modified triphosphates, and/or oligonucleotides, in a regulated manufacturing environment. Collaborate with cross-functional teams to both (1) address operational sustaining needs (i.e. resolve production issues related to safety, yield, quality, and/or throughput) and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products Represents Operations’ needs in cross-functional meetings to ensure quality, continuity and efficiency of products and processes transferred to and implemented within manufacturing teams. Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements. Analyze, trends, monitors and updates Manufacturing KPIs and metrics. Support non-conformances/CAPA’s through providing technical evaluations and investigations. Support continuous improvement and sustaining activities. Aid in the selection of appropriate components and vendors in area of responsibility. Support the transfer of manufacturing processes between manufacturing locations. Facilitate productive cross-site and cross-functional relationship between manufacturing sites. Able to plan and prioritize assigned tasks and activities with minimal guidance. Execution of tasks with guidance from project lead or manager. Provides technical decisions in own area of responsibility. Tracks component COGS and associated project expenses   Requirements: Demonstrated ability to make oligonucleotides, nucleotides, and/or associated subassemblies Manufacturing experience of organic synthesis is highly desirable Working knowledge and experience of automated synthesis, preparative and analytical chromatography.  LC-MS and ability to interpret NMR is desirable. Experience in process support and development in a GMP environment Strong analytical, problem solving, troubleshooting, and root cause analysis skills Strong interpersonal, verbal and written communication skills required Must be detail oriented Strong understanding of GMP Experience with standard laboratory practices Strong computer skills are required. Programming knowledge is a plus. Experience with SAP or equivalent ERP system Experience working in an ISO 13485 or FDA regulated environment is desirable Experience with lean manufacturing tools and principles is a plus Experience with statistics, Statistical Process Control and DOE techniques is desirable   Education: MS Degree in Organic Chemistry, Chemistry, Molecular Biology/Biochemistry, Chemical Engineering, Biochemical Engineering or similar discipline with 1+ years of related experience BS Degree in Organic Chemistry, Chemistry, Molecular Biology/Biochemistry, Chemical Engineering, Biochemical Engineering or similar discipline with 3+ years of related experience   Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.  Changes to individual responsibilities may occur due to business needs.     Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Apply