Plant Maintenance & Engineering Manager (GMP Operations)

Edwards Lifesciences; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Edwards Lifesciences is seeking a Maintenance/Facilities Manager to lead GMP-regulated maintenance in Irvine, CA. You will oversee teams, manage capital projects, ensure regulatory compliance, and partner with operations to optimize equipment performance.

The role requires onsite work, 5+ years in maintenance/engineering with leadership experience, and knowledge of Maximo CMMS and HVAC systems. Weekend on-call availability may be required.

Qualifications

• Bachelor's degree in Engineering or related 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 and weekend/off-hours availability.

Responsibilities

• 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 (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.

Skills

Maintenance leadership

Regulatory compliance

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in Engineering

Tools

Maximo CMMS

HVAC knowledge

Job description

Edwards Lifesciences is seeking a Maintenance/Facilities Manager to lead GMP-regulated maintenance in Irvine, CA. You will oversee teams, manage capital projects, ensure regulatory compliance, and partner with operations to optimize equipment performance.

The role requires onsite work, 5+ years in maintenance/engineering with leadership experience, and knowledge of Maximo CMMS and HVAC systems. Weekend on-call availability may be required.