Schedule: Tuesday to Saturday, 7:30 a.m.-4:30 p.m.The Manager will provide strategic and operational leadership for plant maintenance, facilities, and engineering in a GMP-regulated manufacturing environment. Ensure equipment reliability, facility performance, safety, regulatory compliance, operational excellence, and cost-effective project execution.
How you'll make an impact:- Lead maintenance and facilities teams, manage staffing, establish priorities, and develop technical capabilities.
- Oversee preventive, predictive, corrective, and emergency maintenance to minimize downtime and improve equipment performance.
- Ensure GMP, SOP, GDP, and regulatory compliance, including deviations, CAPAs, and change controls.
- Manage capital projects, facility improvements, equipment upgrades, commissioning, and qualification.
- Maintain accurate records, work orders, risk assessments, and equipment history through CMMS (preferably Maximo).
- Partner with cross-functional teams and contractors while enforcing EHS, LOTO, JSA, and risk management requirements.
- Monitor KPIs, optimize resources, and manage operating and capital budgets.
What you'll need (Required):- Bachelor's degree in Engineering or a related technical field, or equivalent experience.
- Minimum 5 years of relevant maintenance, facilities, or engineering experience, including 2 years in leadership.
- Experience in regulated manufacturing, preferably medical devices or pharmaceuticals.
- Strong technical problem-solving, team leadership, and cross-functional collaboration skills.
- Onsite required to support manufacturing operations.
- Availability to support critical operations and off-hours emergencies which may include weekends.
What else we look for (Preferred):- Experience with GMP facilities, cleanrooms, critical utilities, laboratories, and production equipment.
- Proficiency in Maximo.
- Experience managing capital projects, contractors, commissioning, qualifications, and budgets.
- Knowledge of GMP, 21 CFR Parts 210/211, applicable medical-device regulations, ICH Q9/Q10, and inspection readiness.
- Proficiency in ALCOA principles, data integrity, CAPA, change control, investigations, and risk assessments.
- Understanding of DQ/IQ/OQ/PQ, equipment qualification, and acceptance criteria.
- Knowledge of HVAC, cleanrooms, environmental controls, purified water/WFI, compressed gases, electrical systems, and building automation.
- Experience with CMMS, BMS/EMS/SCADA, calibration, electronic quality systems, and applicable 21 CFR Part 11 requirements.
- Application of FMEA, asset criticality, predictive maintenance, PM optimization, spare-parts management, MTBF, and MTTR.
- Knowledge of contamination control, contractor safety, audits, budgets, contracts, and capital expenditures.
- Demonstrates technical expertise, accountability, effective communication, and sound decision-making.
- Develops employees, manages competing priorities, and promotes a culture of safety, quality, compliance, teamwork, and continuous improvement.
