Facilities & Maintenance Manager

Facilities & Maintenance Manager

The Facilities & Maintenance Manager is a hands-on technical leader responsible for the daily reliability, performance, and compliance of facility, utility, manufacturing, filling, and packaging systems across the 503A and 503B operations. This role is actively engaged on the production floor, directly troubleshooting equipment, leading maintenance execution, and driving real-time solutions that protect sterile operations and business continuity.

• Develop and lead maintenance team through direct floor engagement, accountability, training, and performance management.
• Full ownership of site-wide maintenance across manufacturing, filling, packaging, utilities, and infrastructure for 503A and 503B operations.
• Ensure >98–100% on-time preventive and predictive maintenance execution; drive rapid response to equipment failures.
• Lead hands‑on troubleshooting of critical systems including HVAC, clean rooms, water for Injection, compressed gases, and sterile processing equipment.
• Own and manage the complete calibration program; maintain 100% compliance and audit readiness.
• Investigate out-of-tolerance and equipment-related deviations; implement effective root cause and CAPA solutions.
• Serve as system owner for BMRAM (CMMS); ensure accurate asset records, timely work order closure, KPI tracking, and data integrity.
• Own Lighthouse environmental monitoring system; ensure continuous ISO compliance, alarm functionality, trend review, and excursion management.
• Maintain validated state of facilities, utilities, and monitoring systems; support inspections as technical SME.
• Lead capital projects from specification through commissioning (URS, FAT, SAT, IOQ, PQ) with direct contractor oversight.
• Control maintenance and calibration budgets while optimizing spare parts inventory and reliability metrics (MTBF, downtime reduction).
• Drive continuous improvement initiatives using Lean/Kaizen to enhance uptime, throughput, and GMP compliance.
• Develop and implement solutions to difficult problems, manage outside contractors and be on call for emergencies.
• Manage spare parts inventory to balance cost control with operational reliability.
• Ensure facility and utility systems consistently meet ISO classifications, pressure cascades, and environmental control requirements.
• Lead change management, risk assessments (FMEA), and impact evaluations related to facility, equipment, and utility modifications.
• Coordinate and oversee third‑party contractors and service providers to ensure GMP‑compliant execution and documentation.
• Partner cross‑functionally with Operations, Quality, Validation, and Supply Chain to align maintenance strategy with production readiness and business continuity objectives.

• Bachelor’s degree in Mechanical or Electrical Engineering preferred; equivalent hands‑on experience considered.
• Minimum 5 years in GMP pharmaceutical manufacturing.
• Minimum 3 years managing maintenance teams in sterile or regulated environments.
• Demonstrated hands‑on troubleshooting of manufacturing equipment and critical utilities.
• Direct experience managing CMMS systems (BMRAM or equivalent).
• Experience overseeing environmental monitoring systems (Lighthouse or equivalent).
• Strong knowledge of HVAC, cleanroom classifications, utilities, and GMP documentation practices.
• Experience supporting regulatory inspections.
• Commitment and drive to improve manufacturing operations.
• Perform other duties, as assigned.

On‑Site

Up to 10%