Manufacturing Engineer

We're looking for a highly motivated Manufacturing 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. 

As the Manufacturing Engineer, you will provide essential technical support for the Fremont site’s Validation program and facility operations. This role is a mix of hands-on technical execution and project coordination, ensuring that manufacturing equipment and site utilities are validated, qualified, and maintained in a continuous state of compliance with global regulatory expectations. 

Responsibilities

• Owning the site-wide Validation program, ensuring all systems and equipment are maintained in a validation state appropriate for the phase of development for which they are utilized.
• 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.
• Owning the Periodic Assessment and Requalification program with on-time executions to ensure compliance with regulatory and company expectations, policy and procedure including Classified room and BSC Certifications.
• Accountable for phase appropriate Aseptic Process Simulation and Cleaning validation programs.
• Generating, executing and defending lifecycle documentation, including System Impact Assessments, URS, FMEAs, Master Validation Plan and IQ/OQ/PQ protocols. Standardize and improve business processes for equipment intake, periodic reviews, and change control to increase site efficiency and compliance.
• System Owner for Facility Management System (FMS), the qualified process and facility parameter monitoring and alarming system including ownership of FMS alarm management. Ensure appropriate alarm set points, time delays and notifications. 
• 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 including Capital funding and change control management.
• 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 4-6+ 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.
• Validation Program Management: Proven track record owning site-wide Validation programs, including the implementation of VMP and site procedures, a 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 $108,000 - $127,000, 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.