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.
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.
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.
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.
About GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. 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. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.
We are committed to an inclusive and diverse GeneFab. 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. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
