Full-time

Description

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

Job Summary

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.

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.

Requirements

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.

Preferred Certifications

Certified Safety Professional (CSP)
OSHA 30-Hour Certification
Certified Industrial Hygienist (CIH)
Facilities Management certifications (IFMA, BOMI, etc.) preferred
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.

Why Join Biomerics?

At Biomerics, you will be part of a collaborative and growth-oriented organization dedicated to improving lives through innovation and manufacturing excellence. We value individuals who are passionate about building strategic customer partnerships and driving operational and commercial success within the medical device industry.

Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k.

**The salary estimates are estimates from this job board and not a guarantee from Biomerics' salary range.

Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics, and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.

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