Senior Maintenance, Reliability, and Calibration Engineer (GMP)

GeneFab•Alameda, CA

1d•$145,000 - $180,000

About The Position

The Senior Maintenance, Reliability, and Calibration Engineer is responsible for driving asset performance, operational uptime, and regulatory compliance across all GMP manufacturing, packaging, and clean utility systems. This role serves as the site owner for calibration and maintenance programs—overseeing the planning, scheduling, and compliant execution of all technical work. The ideal candidate will combine deep reliability engineering expertise with hands-on mastery of metrology and maintenance management systems to ensure the facility consistently operates within its validated state.

Requirements

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.
Proven track record managing instrument calibration programs, loop testing, and metrology standards.
Direct experience leading maintenance planning/scheduling functions.
Strong working knowledge of 21 CFR Part 11, Part 210/211, and EU Annex 1 regulations, specifically regarding calibration tolerances and instrument impact assessments.
Deep familiarity with clean utilities and processing equipment, including a strong understanding of sanitary design principles and automated control systems (DeltaV, PLC).
Proven experience authoring and managing Deviations, RCAs, CAPAs, and Change Controls within automated quality management systems (e.g., TrackWise, Veeva).
Advanced proficiency with validated CMMS platforms (specifically Blue Mountain RAM, Maximo, or SAP) for managing compliant asset histories, PMs, and calibration work orders.

Nice To Haves

Certified Maintenance & Reliability Professional (CMRP) or Certified Reliability Engineer (CRE) designation.
Experience in a commercial-scale Cell & Gene Therapy or Biologics facility.
Six Sigma Green or Black Belt certification.

Responsibilities

Own the end-to-end lifecycle of the site’s Preventative Maintenance (PM) and Calibration programs.
Lead the maintenance planning and scheduling workflow to ensure zero disruption to production schedules while maximizing technical team efficiency.
Define calibration requirements, tolerances, and loop checks for all process instrumentation and critical utilities.
Manage the site calibration schedule, analyze instrument drift data to optimize calibration frequencies, and resolve out-of-tolerance (OOT) investigations.
Develop and optimize maintenance strategies for critical process equipment (bioreactors, purification columns, filling lines) and clean utilities (WFI, purified water, clean steam, GMP HVAC) without compromising validated boundaries.
Lead technical investigations for equipment-related deviations, non-conformances, and OOT events.
Utilize formal Root Cause Analysis (RCA) methodologies to implement robust Corrective and Preventive Actions (CAPAs).
Author, review, and execute Quality Change Controls for equipment modifications, optimization projects, or component obsolescence, ensuring zero negative impact on product quality or regulatory compliance.
Act as a key business owner for the Computerized Maintenance Management System (CMMS).
Ensure all maintenance and calibration data, logs, asset histories, and electronic signatures strictly adhere to ALCOA+ data integrity principles and 21 CFR Part 11.
Serve as the Subject Matter Expert (SME) for calibration and maintenance programs during regulatory inspections (FDA, EMA) and internal quality audits.
Oversee specialized GMP service contractors, ensuring their documentation and execution meet site quality standards.
Establish a risk-based GMP spare parts strategy, aligning critical spares with equipment criticality assessments to minimize stockouts of long-lead maintenance and calibration components.