The Manufacturing Technical Operations (MTO) team in San Diego is a part of Global Quality & Operations at Illumina and has responsibility for processes and equipment in Reagent manufacturing operations. The Senior Manufacturing Equipment Engineer will be part of the MTO organization and support Reagent manufacturing. The candidate will need to be skilled in the use of PLC, HMI devices, Robotics, Vision Systems, Pneumatics and Servo Motors. The candidate should have experience commissioning, operating and sustaining complex automated systems in a high-volume manufacturing environment. This person will join a dynamic, fast paced organization supporting new product development, as well as sustaining operations.
Participate in the specification development, commissioning (FAT, SAT), and validation (IQ/OQ/PQ) activities of new equipment/automated systems
Responsible for troubleshooting and fixing issues with large automated systems including: PLC, HMI devices, Pneumatics, Servo Motors, Vision Systems and Robotics
Support maintenance and troubleshoot computer and networking issues in relation to SCADA and DCS systems
Hands on investigation and troubleshoot manufacturing issues with a sense of urgency to prevent line down situations.
Designs, improves and implements production equipment/processes, fixtures/jigs for production equipment and assembly to improve product quality, increase productivity or reduce costs.
Establish and maintain the reliable and qualified operation of the reagent fill lines for both existing and new assets.
Perform Engineering Studies and re-qualifications of automated fill lines and other equipment
Optimize existing automated lines to improve performance, robustness and quality
Identify and lead projects to resolve and improve equipment reliability
Provide training and coaching to engineers and technicians on new and existing equipment and procedures.
Collaborate with cross-functional teams including Manufacturing, Process Engineering, Quality and Product Development Team.
Experience and understanding of complex automated manufacturing systems, tools and components (electrical and pneumatic control, sensors, metrology systems, PLCs) required
Experience with equipment qualifications/validation (URS, FAT, SAT, IQ, OQ & PQ) required
Experience in troubleshooting PLCs (Beckhoff, Allen Bradley)
Hands on experience with controls equipment including PLCs, HMIs, SCADA systems, and networking equipment
Experience with Solidworks to create models and drawings for equipment designs. Perform Mechanical tooling and fixture design for equipment improvements.
Writing protocols, test scripts, user requirements, and system design documents experience preferable
Ability to troubleshoot and supervise all aspects of electrical control systems and equipment used in our automated manufacturing systems
Deep knowledge in the use of industrial automation devices (i.e. sensors, switches, load cells, cylinders, valves, motors, encoders, etc.)
Demonstrated use of Lean Six Sigma tools for continuous improvement
Experience with Total Productive Maintenance (TPM) program and OEE metrics
Effective communication skills both verbal and written, analytical and organizational skills to manage different priorities
Must have the ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches
Self-directed mindset with high energy and works with minimal supervision or guidance
Proficient in Microsoft Office Suite, including Outlook, Word, Excel and PowerPoint
Working knowledge of the principles of Industry 4.0
Must be willing to participate in an on-call rotation
Travel up to 20% as required
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Degree in Mechanical Engineering with experience in control systems and software
5+ years of system engineering experience, supporting automated manufacturing equipment preferably within biotech or medical device industries
Experience with liquid handling, tube filling, labeling and capping automation desirable
Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment highly preferred
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