Calibration & Facilities Engineer

Location: Fremont

Department: Operations

We are looking for an enthusiastic, experienced Engineer to join our team in Fremont. Reporting to the Senior 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 (HVAC, electrical, and mechanical) are calibrated, maintained, and compliant with site standards. You will be directly contributing to our groundbreaking programs and our mission to develop bioprinted tissue therapeutics to transform the lives of people with serious diseases.

Responsibilities

• Executing the site-wide metrology program, coordinating the calibration and maintenance of all instrumentation to ensure systems remain within established tolerances and support a validated state of operation.
• Supporting the Commissioning, Qualification, and Validation (CQV) of manufacturing equipment and facility utilities (HVAC, water, and gas systems) under the guidance of the Senior Engineer, applying risk-based strategies and GAMP5 standards.
• Drafting and maintaining lifecycle documentation, including URS, FMEAs, and IQ/OQ/PQ protocols. Assisting in the standardization of equipment intake processes and periodic reviews to increase site efficiency.
• Coordinating with the Manufacturing team during the installation and modification of new systems, acting as a technical resource for equipment design reviews and technology transfers.
• Monitoring facility operations and utilities as well as supporting the maintenance of HVAC and mechanical systems to ensure cleanroom environments and production areas meet performance specifications.
• Managing and handling facility gas systems, including under GMP requirements (daily checks, inventory control of gas cylinders/spares, physically changing/replacing cylinders, etc).
• Assisting in regulatory inspection readiness by organizing engineering and validation packages (FDA, EMA, etc.) and acting as a secondary Subject Matter Expert (SME).
• Administering the Maintenance Management System (CMMS), BMS, FMS, performing data entry and tracking for the asset registry, PM schedules, and replacement parts inventory. Assisting in root-cause investigations for equipment failures or out-of-tolerance events will be among your duties. 
• Facilitating vendor management and test scheduling, ensuring third-party contractors complete calibrations, repairs, preventive maintenance, equipment install, and external IQ/OQ testing on time and in compliance with site safety, quality, and Good Documentation Practice (GDP) standards.
• Overseeing the security of site, facility maintenance and cleaning of controlled and non-controlled areas.
• Creating and maintaining accurate documentation, SOPs, and records for calibrations, maintenance, facility, and utilities. 
• Other duties as required.

Qualifications & Experience

• Experience & Education: A bachelors or masters in engineer and 3–5 years of experience in a regulated industry (Biotech, Pharma, or Med Device), with a strong preference for experience in metrology or facility engineering. We will consider applicants with a mix of industry and educational background.
• Skills: Knowledge of NIST standards, HVAC, Utility Systems (including WFI, gases), and the ability to coordinate multiple vendor schedules simultaneously.
• You have familiarity with reading and interpreting P&IDs, drawings, specifications also, reviewing turnover packages, vendor documentation.
• You have familiarity with conducting or coordinating FAT and SAT testing
• 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.
• You have outstanding attention to detail as well as experimental and process rigour. You take pride in your work and strive for excellence.

The hiring range for this role is $94,000 - $102,000, 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.