Facilities and EHS Manager
Our client is a growing medical device manufacturer with a global footprint and a strong reputation for quality, compliance, and innovation. Operating within a highly regulated manufacturing environment, the organization is investing heavily in its facilities infrastructure and future growth initiatives.
About the role
This position offers a unique opportunity to lead facility operations while serving as the site lead for a major facility buildout and expansion project. Reporting directly to the VP of Operations, this individual will oversee Facilities, EHS, Security, Business Continuity, Capital Projects, and contractor management while ensuring compliance with FDA, ISO 13485, OSHA, and environmental regulations.
Responsibilities
- Lead all facility operations, infrastructure management, and preventive maintenance programs for a regulated medical device manufacturing facility.
- Serve as the site lead for facility expansions, buildouts, renovations, relocations, and capital projects from planning through commissioning and occupancy.
- Manage general contractors, subcontractors, architects, engineers, and vendors while maintaining project schedules, budgets, and project deliverables.
- Oversee contractor selection, bidding processes, contract negotiations, change orders, and project execution.
- Coordinate HVAC, electrical, plumbing, utilities, fire protection, security systems, environmental controls, and other critical building infrastructure.
- Support construction, commissioning, qualification, validation, and change control activities within a regulated manufacturing environment.
- Establish, improve, and maintain preventive maintenance programs for facility infrastructure and facility equipment.
- Lead Environmental Health & Safety programs and ensure compliance with OSHA, EPA, environmental permits, hazardous waste regulations, and emergency response requirements.
- Manage facility security systems including badge access, visitor management, CCTV, and alarm systems.
- Support FDA, ISO 13485, customer, and internal audits while maintaining an inspection-ready facility.
- Partner closely with Operations, Quality, Engineering, and Regulatory teams to support site growth and continuous improvement initiatives.
Requirements
- Direct experience managing cleanroom construction, cleanroom expansions, or major cleanroom renovations in a medical device, pharmaceutical, biotech, or other FDA-regulated manufacturing environment.
- Demonstrated success leading facility buildouts, expansions, relocations, or major capital projects from concept through commissioning and occupancy.
- Hands-on experience managing general contractors, subcontractors, schedules, budgets, bids, contract negotiations, and change orders.
- Experience overseeing construction and installation of facility systems including HVAC, electrical, plumbing, utilities, fire protection, security systems, and environmental controls.
- Strong understanding of commissioning, qualification, validation, and change control within a regulated manufacturing environment.
- Experience establishing and maintaining preventive maintenance programs for facility infrastructure and facility equipment.
- Background within a medical device, pharmaceutical, biotech, or similarly regulated manufacturing environment.
- Minimum 7+ years of facilities leadership, facilities engineering, or facilities management experience.
Preferred Qualifications
- Experience supporting FDA, GMP, ISO 13485, or comparable regulated manufacturing standards.
- Bachelor's degree in Engineering, Facilities Management, Construction Management, Industrial Technology, or a related technical discipline.
Why This Opportunity Stands Out
- Lead a high-visibility facility expansion and infrastructure improvement initiative.
- Direct ownership of facility operations, capital projects, contractor management, and site development.
- Opportunity to oversee cleanroom, laboratory, and regulated manufacturing environments.
- Strategic leadership role reporting directly to the VP of Operations.
- Broad responsibility across Facilities, EHS, Security, and Business Continuity.
- Significant influence on the site's long-term growth strategy and operational performance.
Pay
$95,000+ base salary with a 20% target bonus.