Equipment and Facilities Engineering Manager
AI Summary
Lead the equipment and facilities engineering function at a medical device manufacturer, managing maintenance, capital projects, regulatory compliance, and technical staff.
About this role
Our client, a growing medical device manufacturer, is hiring an Equipment and Facilities Engineering Manager to lead engineering and maintenance at its Richland manufacturing site. This person will own equipment reliability, facility readiness, capital projects, and regulatory compliance while leading technical staff and outside service partners. The role works closely with Manufacturing, Quality, Regulatory Affairs, Supply Chain, Research and Development, and Environmental Health and Safety.
What You Will Do
- Lead the equipment and facilities engineering function, including engineering staff, maintenance technicians, contractors, and service providers.
- Oversee preventive, predictive, and corrective maintenance programs, reliability metrics, maintenance KPIs, and asset management to improve equipment uptime and lifecycle performance.
- Lead capital projects, including facility expansions, equipment installations, process improvements, utility upgrades, and infrastructure modernization, from planning through closeout.
- Support equipment commissioning, qualification, validation, and startup activities, including IQ, OQ, and PQ documentation when applicable.
- Manage critical facility systems, utilities, cleanrooms, and controlled manufacturing environments, including HVAC, electrical distribution, compressed air, water, environmental controls, and security.
- Partner with Quality and Regulatory Affairs to support ISO 13485, FDA, and cGMP compliance, including audits, inspections, SOPs, and equipment documentation.
- Lead root-cause investigations, CAPAs, corrective actions, and continuous-improvement initiatives involving equipment, utilities, and facility performance.
- Manage capital and operating budgets along with engineering service providers, contractors, equipment suppliers, and maintenance vendors.
- Support new product introductions, process transfers, and manufacturing scale-up by ensuring equipment and facility readiness.
- Maintain emergency-response, business-continuity, and facility risk-management plans and provide regular updates to executive leadership.
Requirements
- Bachelor's degree in mechanical, electrical, industrial, manufacturing, chemical engineering, or a related technical discipline.
- At least eight years of experience in facilities engineering, manufacturing engineering, maintenance engineering, reliability engineering, or a related technical field.
- At least four years of leadership experience managing engineers, maintenance personnel, contractors, or technical teams.
- Experience supporting regulated manufacturing operations and managing facility infrastructure, utilities, manufacturing equipment, and maintenance programs.
- Experience leading capital projects from planning through execution and closeout.
- Demonstrated experience with preventive maintenance, reliability programs, root-cause analysis, technical troubleshooting, and continuous improvement.
- Experience managing contractors, vendors, budgets, resources, and multiple projects, with strong communication skills and proficiency in Microsoft Office applications.
Preferred Experience
- Experience in medical device, pharmaceutical, biotechnology, semiconductor, nuclear, aerospace, or another highly regulated manufacturing environment.
- Working knowledge of ISO 13485, FDA regulations, GMP requirements, and validation principles.
- Experience supporting ISO Class 7 or 8 cleanrooms, controlled or sterile manufacturing environments, and equipment qualification activities, including IQ, OQ, and PQ.
- Experience using CMMS, ERP, and asset-management systems.
- PMP, Certified Maintenance and Reliability Professional, Lean Six Sigma, or a similar certification.
Compensation
The base salary range for this position is $125,000 to $155,000 annually. Actual compensation will be determined based on experience, qualifications, and other job-related factors.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401K, IRA)
- Paid Time Off (Vacation, Sick, & Public Holiday)
Skills
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