Manager, Maintenance, Plant Operations Engineering

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.