Mid-level CQV Engineer - (LS-00004M)

  • Jacobs
  • United States-Massachusetts-Cambridge-US MA Cambridge - Sanofi Aventis Us Llc
  • Jul 10, 2020
Full time Construction

Job Description

Description
 Our People & Places Solutions business – reinforces our drive to improve the lives of people everywhere and epitomizes the "why" of what we do – the tremendous positive impact and value our solutions bring to our communities and society as a whole. From facilities delivering life-saving therapies and ensuring clean water to enabling the connection of people through all modes of transportation and providing access to technology – we're integrating a multitude of these solution elements to build the smart environments of tomorrow.

Start your Jacobs career with a company that inspires and empowers you to deliver your best work so you can evolve, grow and succeed – today and into tomorrow.


The Commissioning, Qualification and Validation (CQV) Engineer will provide CQV services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products. This position shall be responsible for the development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.


Technical/Functional Responsibilities:
Provide CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices:
  •  Develop CQV planning documents to manage CQV projects
  • Generate and execute CQV protocols using Good Documentation Practices (GDPs)
  • Investigate and resolve protocol exceptions or discrepancies
  • Develop technical reports and CQV summary reports
  • Startup equipment in a safe and effective manner
  • Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.)
  • Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation
  •  Perform risk assessments and impact assessments
  • Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients
 
Qualifications
 Minimum Qualifications:
The ideal candidate for this position will possess the following:
  • BS in Mechanical, Chemical or Electrical Engineering or equivalent
  • 8-14 years of CQV experience in the life sciences industry
  • Understanding of Good Manufacturing Practices (GMPs)
  • Technical writing skills
  • Proficient with Microsoft Office – Word, Excel, PowerPoint, Project
  • Flexibility and willingness to travel and work at various clients’ locations
  • Ability to work well with diverse, multi-disciplined groups
  • Ability to effectively communicate with management and fellow project team members
  • Ability to negotiate/compromise with other project team members to achieve project goals
  • Ability to listen and respect fellow project team member’s ideas and opinions and work through conflicts or disagreements

Preferred Qualifications:
  • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
  • Knowledge of industry guidance:
    • ISPE Baseline Guide 5 Commissioning and Qualification
    • ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
    • ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    • ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
    • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
  • Six Sigma Certification
#AF #LifeSciences
 

Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Learn more about your rights under Federal EEO laws and supplemental language.

 

Primary Location

: United States-Massachusetts-Cambridge-US MA Cambridge - Sanofi Aventis Us Llc

Job Posting

: Jul 6, 2020, 7:42:41 PM

Job

: Engineering

Organization

: PPS

Job Type

: Experienced
Job Classification: Full-Time Regular

Work Locations

: 
US MA Cambridge - Sanofi Aventis Us Llc 
270 ALBANY STREET  
 Cambridge 02140
Capabilities: Life Sciences and Biopharma