Lead GMP Engineer - Cell Therapy Validation & Metrology

We're looking for a highly motivated Senior/Lead Engineer to join our dynamic Technical Operations team in Fremont, California. Reporting to the Chief Technical Operations Officer, you will be instrumental in evolving our GMP processes and instrumentation for clinical manufacturing. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. Responsibilities Owning the site-wide metrology program, ensuring all instrumentation is calibrated, maintained, and performing within established tolerances to support a validated state of operation. Leading the commissioning and qualification (C&Q) of systems for pre-clinical and clinical cell therapy manufacturing, applying risk-based strategies. Ensure all systems meet GAMP5 and Data Integrity standards. Generating and defending lifecycle documentation, including System Impact Assessments, URS, FMEAs, and IQ/OQ/PQ protocols. Standardize and improve business processes for equipment intake, periodic reviews, and change control to increase site efficiency and compliance. Serving as the primary engineering partner for R&D and Manufacturing during the design and modification of new systems, participating in design reviews and technology transfers. Successfully defend engineering and validation packages during internal and regulatory inspections (FDA, EMA, Health Canada), serving as the Subject Matter Expert (SME) for equipment reliability and data integrity. Directing resource allocation and test scheduling for complex engineering projects, ensuring timelines are met without compromising quality or safety. Implementing an effective Maintenance Management System including asset registry, PM schedule, work order tracking, replacement parts inventory and tracking, and metrology and calibration tracking. Lead root-cause investigations into equipment failures. Qualifications Education & Experience: You hold a Bachelor's or Master's in Engineering or another relevant discipline and 6-8+ years of progressive experience. You have demonstrated success in leading complex technical projects and providing mentorship to junior team members. Engineering Lifecycle & C&Q Leadership: Extensive experience leading Risk-Based Commissioning and Qualification (C&Q) for cell therapy manufacturing, including the generation and defense of URS, FMEA, and IQ/OQ/PQ protocols in compliance with GAMP5 and Data Integrity standards. Metrology & Asset Management: Proven track record owning site-wide metrology and maintenance programs, including the implementation of CMMS for asset tracking, PM scheduling, and root-cause investigations within a validated FDA/EMA/Health Canada regulated environment. Intellectually Curious: You have a burning desire to learn more and aren’t afraid to ask questions. Problem Solver: You love immersing yourself in difficult technical problems and coming up with solutions that work. You think outside the box and use your experience and intuition to identify when such solutions are realistic. The hiring range for this role is $128,452 - $136,000, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression. All aspects of employment — including the decision to hire, promote, discipline, or terminate — are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, citizenship status, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, political affiliation, or any other status protected under federal, state, provincial, or local law. #J-18808-Ljbffr Aspect Biosystems