Senior Maintenance, Reliability, and Calibration Engineer (GMP)
On-site · Alameda, California, United States
Job Summary
Senior Maintenance, Reliability, and Calibration Engineer to own the end-to-end lifecycle of the site’s Preventative Maintenance and Calibration programs at GeneFab’s GMP biopharma site. Lead maintenance planning and scheduling to avoid production disruption while maximizing technical team efficiency. Define calibration requirements, tolerances, and loop checks for process instrumentation and critical utilities; manage calibration schedules and analyze drift data to optimize frequencies and resolve out-of-tolerance events. Develop maintenance strategies for critical process equipment (bioreactors, purification columns, filling lines) and clean utilities (WFI, clean steam, GMP HVAC) within validated boundaries. Lead technical investigations for deviations, non-conformances, and OOT events using RCA methodologies to implement robust CAPAs. Author and execute Quality Change Controls for equipment modifications or obsolescence to ensure product quality and regulatory compliance. Act as SME for CMMS, ensuring data integrity per ALCOA+ and 21 CFR Part 11. Prepare for regulatory inspections (FDA, EMA) and internal audits; oversee GMP service contractors. Establish a risk-based spare parts strategy to minimize stockouts of long-lead components.”,/
Required Qualifications
- Bachelor’s degree in Mechanical, Electrical, Chemical, or Bioengineering, or a related technical discipline
- 6+ years of engineering experience in a highly regulated manufacturing environment, with at least 3-4 years directly within a GMP biopharmaceutical, medical device, or life sciences facility
- Calibration & Planning Expertise: Proven track record managing instrument calibration programs, loop testing, and metrology standards
- Regulatory Knowledge: Strong working knowledge of 21 CFR Part 11, Part 210/211, and EU Annex 1 regulations
- Technical Expertise: Familiarity with clean utilities and processing equipment, including DeltaV, PLCs
- Quality Systems: Experience authoring and managing Deviations, RCAs, CAPAs, and Change Controls within automated quality management systems
- CMMS Proficiency: Proficient with validated CMMS platforms (Blue Mountain RAM, Maximo, SAP) for managing compliant asset histories
- Preferred: CMRP or CRE designation; experience in commercial-scale Cell & Gene Therapy or Biologics; Six Sigma Green/Black Belt.
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