Position Summary
- Supervise and direct facilities maintenance, calibration, and metrology team.
- Manage maintenance, preventive/corrective maintenance, and upkeep of manufacturing/production assets for multiple locations.
- Participate in cross-functional teams to maintain company expectations and standards.
Responsibilities / Essential Functions
- Oversee GMP-standard maintenance and recommend improvements for maintenance, calibration, and safe equipment use across sites.
- Lead, coach, train, and evaluate team members; establish maintenance/metrology/calibration schedules.
- Plan and coordinate preventive/corrective maintenance; provide progress reporting.
- Oversee contractors to ensure compliance (sanitation, safety, quality, scheduling, productivity, budget) and required permits.
- Lead preventive/corrective maintenance of critical plant equipment (Manufacturing/Filling/Sterilization; electrical control systems) in cGMP and non-cGMP areas.
- Repair/replace mechanical, electrical, and control components of Manufacturing, Sterilization, and Packaging equipment.
- Develop strategic plans for maintenance, upgrades, and acquisitions (budgeting/cost estimation/procurement).
- Troubleshoot, diagnose, and repair critical equipment and electrical/control systems.
- Maintain SOPs/work plans/templates, work order status, and calibration/metrology KPI metrics; maintain Measurement Data Template (MDT) and VEEVA documents.
- Ensure CMMS workplan templates are generated and resolve problems proactively; mentor/train.
- Lead required training/meetings; lead/participate in audits and regulatory inspections; perform special projects as assigned.
Qualifications
- Bachelorβs in Engineering/Facilities Mgmt (or related) + 7+ years Process GMP/Mechanical experience; OR 8+ years Process GMP/Mechanical + Maintenance/Utilities Certificate; OR HS diploma + 10+ years Process GMP/Mechanical.
- 5+ years CMMS experience; 3+ years in FDA-regulated environment.
- Knowledge of facilities equipment and preventive maintenance programs.
- Critical Utility Systems experience (WFI, PUW, HVAC, waste neutralization, generators, process utilities).
- Supervisory and/or budget management preferred; Pharma-Biotech manufacturing experience strongly preferred.
Skills / Knowledge
- Instrumentation and mechanical maintenance skills; cGMP, OSHA, EPA, NFPA, HVAC/cleanrooms; automated pharmaceutical processing.
- Strong troubleshooting/repair ability for plant equipment, pumps, sterilization, filtration, filling/packaging, and electrical controls.
- Strong written/verbal communication; teamwork; ability to lead through complex situations.
- Ability to read wiring diagrams/blueprints/P&ID and perform analog/digital/frequency/time calibration.
Compensation
- Annual base pay range: $126,000β$140,000.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).