We're looking for a highly motivated GMP Facilities Engineer to join our dynamic Technical Operations team in Fremont, California. Reporting to the Chief Technical Officer, or designee, you will be instrumental in evolving our Policy, Procedure and Practice in support of Aspect biosystem’s clinical development programs. 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 GMP Facilities Engineer, you will provide essential technical support for the Fremont site’s metrology program and facility operations. This role is a mix of hands-on technical execution and project coordination, ensuring that manufacturing equipment and site utilities (process gases, HVAC, electrical, and mechanical) are calibrated, maintained, and compliant with regulatory expectations and site standards.

Responsibilities

• Coordinate the site-wide calibration and maintenance program; plan, schedule, and track activities (including third-party contractors) to ensure equipment remains validated with minimal impact on manufacturing.
• Support the Commissioning, Qualification, and Validation (CQV) of manufacturing equipment and facility utilities (HVAC, water, and gas systems) in collaboration with the Manufacturing Engineer, System Owners, Contracted Service providers and site QA, applying risk-based strategies and GAMP5 standards.
• Draft and maintain lifecycle documentation, including Engineering Drawings and System descriptions. Assist in the standardization of equipment intake processes and periodic reviews to increase site efficiency.
• Coordinate with the Manufacturing team during the installation and modification of new systems, acting as a technical resource for equipment design reviews and technology transfers.
• Monitor and support the operations of building and clean utilities, including HVAC, mechanical/electrical systems, clean utilities and process gas systems to ensure cleanroom environments and production areas meet performance specifications.
• Monitor and support the operations of building and clean utilities (HVAC, process gases, electrical/mechanical systems) and act as the System Owner for the Building Management System (BMS), including alarm management.
• Assist in regulatory inspection readiness by organizing engineering and validation packages (FDA, EMA, etc.) and acting as a secondary Subject Matter Expert (SME).
• Administer the Computerized Maintenance Management System (CMMS) for asset tracking and PM schedules. Manage inventory control for spare parts and gas cylinders, including physical cylinder changeouts under GMP requirements.
• Facilitate third-party contractor scheduling for calibrations, repairs, preventive and corrective maintenance, and installations, ensuring compliance with site safety, quality, and Good Documentation Practice (GDP) standards.
• Other duties as assigned.

Qualifications & Experience

• Education: You hold a Bachelor in Engineering, another relevant discipline or equivalent experience.
• Experience: 4-6 years of experience in a regulated industry (Biotech, Pharma, or Med Device), with a strong preference for experience in metrology and facility engineering. We will consider applicants with a mix of industry and educational background.
• Skills:
• Knowledge of NIST standards, HVAC, Utility Systems (including WFI, qualified process gases), and the ability to coordinate multiple vendor schedules simultaneously.
• Experience running a CMMS/Work Order ticket system, handling BMS/automation, managing physical security infrastructure, and formal maintenance planning.
• Familiarity with reading and interpreting P&IDs, drawings, specifications also, reviewing turnover packages, vendor documentation.
• 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 $101,000 - $119,000, 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.