Plant Maintenance & Engineering Manager - GMP Facility

Edwards Lifesciences; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Edwards is seeking a Manager of Maintenance, Facilities, and Engineering to lead teams in a GMP-regulated manufacturing environment. You will ensure equipment reliability, safety, regulatory compliance, and cost-effective projects while supporting manufacturing operations on site.

You’ll oversee preventive and predictive maintenance, manage capital projects, and maintain records in CMMS like Maximo. Collaboration with cross-functional teams and contractors, adherence to EHS, LOTO, and CAPA

Qualifications

• Bachelor's degree in Engineering or related field; or equivalent experience.
• Minimum 5 years of maintenance, facilities, or engineering experience; 2 years in leadership.
• Experience in regulated manufacturing (medical devices/pharma).
• Onsite role; able to support after-hours operations.
• Strong technical problem-solving and cross-functional collaboration skills.
• Familiarity with GMP, 21 CFR Parts 210/211 is preferred.

Responsibilities

• Lead maintenance and facilities teams; set priorities and develop capabilities.
• Oversee preventive, predictive, corrective, and emergency maintenance.
• Ensure GMP, SOP, GDP, regulatory compliance incl. CAPAs and deviations.
• Manage capital projects, facility improvements, equipment upgrades, commissioning, and qualification.
• Maintain records, work orders, risk assessments, equipment history in CMMS.
• Collaborate with cross-functional teams and contractors; enforce EHS, LOTO, JSA.
• Monitor KPIs, optimize resources, and manage budgets.

Skills

Leadership

Cross-functional collaboration

Technical problem-solving

Communication

Safety culture

Decision making

Education

Bachelor's degree in Engineering

Tools

Maximo

CMMS

SCADA

BMS

Job description

Edwards is seeking a Manager of Maintenance, Facilities, and Engineering to lead teams in a GMP-regulated manufacturing environment. You will ensure equipment reliability, safety, regulatory compliance, and cost-effective projects while supporting manufacturing operations on site.

You’ll oversee preventive and predictive maintenance, manage capital projects, and maintain records in CMMS like Maximo. Collaboration with cross-functional teams and contractors, adherence to EHS, LOTO, and CAPA