Calibration & Facilities Engineer
Aspect Biosystems · Fremont, CA · 1 mo ago
Manufacturing$101k–$119k/yrFull-time
Responsibilities
- Cook up and maintain a site-wide calibration and maintenance program.
- Support the CQV of manufacturing equipment and facility utilities.
- Draft and maintain lifecycle documentation, including Engineering Drawings and System descriptions.
- Coordinate with the Manufacturing team during the installation and modification of new systems.
- Maintain and monitor the operations of building and clean utilities, including HVAC, mechanical/electrical systems, clean utilities, and process gas systems.
- Manage the Building Management System (BMS) and act as the System Owner for it.
- Assist in regulatory inspection readiness by organizing engineering and validation packages.
- Administer the CMMS for asset tracking and PM schedules.
- Facilitate third-party contractor scheduling for calibrations, repairs, preventive and corrective maintenance, and installations.
Qualifications & Experience
- Education: Bachelor's degree in Engineering or a related field, 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.
- 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: Reading and interpreting P&IDs, drawings, specifications, reviewing turnover packages, vendor documentation.
- Track Record: 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: Burning desire to learn more and not afraid to ask questions.
- Problem Solver: Love immersing in difficult technical problems and coming up with solutions that work. Think outside the box and use experience and intuition to identify realistic solutions.
Pay
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.
Schedule
N/A
Benefits
N/A
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, reviewing turnover packages, vendor documentation.
- 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: Burning desire to learn more and not afraid to ask questions.
- Problem Solver: Love immersing in difficult technical problems and coming up with solutions that work. Think outside the box and use experience and intuition to identify realistic solutions.