GeneFab

Senior Maintenance, Reliability, and Calibration Engineer (GMP)

Alameda, CA · Senior

Sponsorship not specified$145k-$180kDetected 48 days ago

ComplianceSAPProcess ImprovementVendor ManagementPLCControlsGMPFDA RegulatoryCRISPRMedical Devices

About the role

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.

Program Planning & Execution: 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.
Manage the site calibration schedule, analyze instrument drift data to optimize calibration frequencies, and resolve out-of-tolerance (OOT) investigations.
Reliability & Validated State Maintenance: 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.
Deviation & CAPA Ownership: 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).
Spare Parts Strategy: 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.
GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production.
We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team.

Bachelor's degree in Mechanical, Electrical, Chemical, or Bioengineering, or a related technical discipline.
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).
Regulatory Knowledge: Strong working knowledge of 21 CFR Part 11, Part 210/211, and EU Annex 1 regulations, specifically regarding calibration tolerances and instrument impact assessments.
Technical Expertise: Deep familiarity with clean utilities and processing equipment, including a strong understanding of sanitary design principles and automated control systems (DeltaV, PLC).
CMMS Proficiency: Advanced proficiency with validated CMMS platforms (specifically Blue Mountain RAM, Maximo, or SAP) for managing compliant asset histories, PMs, and calibration work orders.
Advanced proficiency with validated CMMS platforms (specifically Blue Mountain RAM, Maximo, or SAP) for managing compliant asset histories, PMs, and calibration work orders.

GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines.
Education: Bachelor's degree in Mechanical, Electrical, Chemical, or Bioengineering, or a related technical discipline.

This listing is sourced directly from GeneFab's careers page and normalized into a canonical job model.