Environmental Health & Safety (EHS) / Facilities Manager
Biomerics · Winston-Salem, NC · 3 wk ago
ManagementFull-time
About the role
The Facilities & Environmental Health & Safety (EHS) Manager is responsible for leading all facility operations, environmental health and safety programs, regulatory compliance activities, and infrastructure maintenance within an ISO 13485-certified medical device manufacturing environment. This role ensures the facility operates safely, efficiently, and in compliance with applicable FDA, OSHA, EPA, local regulatory, and quality system requirements. The Facilities & EHS Manager partners cross-functionally with Operations, Engineering, Quality, and Human Resources to support business objectives, continuous improvement initiatives, and a culture of safety and operational excellence.
Responsibilities
- Develop, implement, and maintain site EHS programs, policies, and procedures to ensure compliance with OSHA, EPA, state, and local regulations.
- Lead safety initiatives focused on injury prevention, hazard identification, risk reduction, and employee engagement.
- Conduct routine safety audits, risk assessments, ergonomic evaluations, and facility inspections.
- Investigate incidents, near misses, and safety concerns; identify root causes and implement corrective and preventive actions (CAPAs).
- Manage required safety training programs including lockout/tagout (LOTO), hazard communication, PPE, emergency response, forklift safety, and chemical handling.
- Maintain OSHA logs, environmental records, permits, and required compliance documentation.
- Serve as the site emergency response coordinator and oversee emergency preparedness programs including fire protection systems, evacuation procedures, and business continuity planning.
- Partner with leadership to drive a proactive safety culture and continuous improvement in EHS performance metrics.
Facilities Management
- Oversee day-to-day facility operations including maintenance, repairs, security, and building systems.
- Identify and diagnose facility issues; implement timely improvements with minimal operational disruption.
- Ensure proper operation, monitoring, and compliance of controlled environments (ISO 8 cleanrooms), including HVAC performance, pressure differentials, particulate control, and gowning practices.
- Lead facility upgrades, remodels, and capital improvement (CAPEX) projects, ensuring timelines, budgets, and quality standards are met.
- Plan and execute building improvements and system upgrades (electrical, plumbing, HVAC, building conditioning).
- Improve-upon and manage preventive maintenance programs for facilities and equipment.
- Manage service contracts and vendor relationships (janitorial, HVAC, landscaping, security, etc.).
- Manage the facility’s janitorial program and ensure a clean, well-maintained, and compliant office and manufacturing environment.
- Check and verify completed work from vendors and contractors.
Quality & Regulatory Compliance
- Ensure facilities and EHS systems comply with ISO 13485, FDA Quality System Regulations (21 CFR Part 820), and applicable customer requirements.
- Support internal audits, external audits, customer audits, and regulatory inspections.
- Participate in nonconformance investigations, CAPAs, change controls, and risk management activities related to facilities and EHS.
- Maintain documentation and records in accordance with document control requirements.
- Collaborate with Quality and Operations teams to support manufacturing continuity and compliance objectives.
Leadership & Continuous Improvement
- Lead and develop maintenance and EHS personnel, including performance management, coaching, and training.
- Establish and track key performance indicators (KPIs) related to safety, maintenance, downtime, and facility performance.
- Drive continuous improvement initiatives focused on operational reliability, safety performance, energy efficiency, and cost reduction.
- Support lean manufacturing and operational excellence initiatives throughout the facility.
Qualifications
- Bachelor’s degree in Environmental Health & Safety, Engineering, Facilities Management, Industrial Technology, or related field preferred.
- 5+ years of experience in facilities management and/or EHS leadership within a regulated manufacturing environment.
- Experience in medical device, pharmaceutical, biotechnology, or other FDA-regulated manufacturing strongly preferred.
- Working knowledge of ISO 13485, GMP, OSHA, EPA, and FDA regulatory requirements.
- Experience managing facility infrastructure systems and maintenance programs.
- Strong knowledge of risk assessment methodologies, incident investigation, and CAPA processes.
- Demonstrated project management and contractor management experience.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Proficiency with Microsoft Office and maintenance/EHS management systems.
Skills
- Preferred Certifications: Certified Safety Professional (CSP), OSHA 30-Hour Certification, Certified Industrial Hygienist (CIH), Facilities Management certifications (IFMA, BOMI, etc.)
- Ability to walk manufacturing and warehouse environments regularly.
- Ability to lift up to 25 pounds occasionally.
- Ability to work around manufacturing equipment, chemicals, and mechanical systems while utilizing required PPE.
Benefits
- Medical/Dental/Vision Insurance
- Short-Term Disability
- Long-Term Disability
- Life Insurance
- Paid Vacation Days
- Paid Holidays
- 401k