Calibration & Facilities Engineer
About The Position
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.
Requirements
- A bachelors or masters in engineer
- 3–5 years of experience in a regulated industry (Biotech, Pharma, or Med Device)
- Knowledge of NIST standards, HVAC, Utility Systems (including WFI, gases)
- Ability to coordinate multiple vendor schedules simultaneously
Nice To Haves
- Strong preference for experience in metrology or facility engineering
- Familiarity with reading and interpreting P&IDs, drawings, specifications
- Familiarity with reviewing turnover packages, vendor documentation
- Familiarity with conducting or coordinating FAT and SAT testing
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
