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.
Metrology & Calibration Ownership: 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.
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).
Quality Change Control: 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.
CMMS & Data Integrity Management: 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.
Audit Readiness & Vendor Management: 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.
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.
Required Qualifications & Skills
Education: Bachelor’s degree in Mechanical, Electrical, Chemical, or Bioengineering, or a related technical discipline.
Experience: 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. Direct experience leading maintenance planning/scheduling functions.
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).
Quality Systems: Proven experience authoring and managing Deviations, RCAs, CAPAs, and Change Controls within automated quality management systems (e.g., TrackWise, Veeva).
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.
Preferred Skills & Qualifications
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.
About Genefab
Genefab is a biofoundry and CRDMO specializing in cell and gene therapy development and manufacturing.
