Jobs · Manufacturing · North Carolina

Environment, Health and Safety Manager

MedPharm · Durham, NC · 2 wk ago
On-siteManufacturingFull-time

About the Role

The Manager of EHS is responsible for leading the Environmental Health and Safety programs and activities in support of MedPharm US sites, including the GMP pharmaceutical manufacturing site and the Research and Development laboratory site. This position represents MedPharm on all regulatory matters related to EH&S across both locations. The EHS Manager develops, manages, and implements environmental health and safety programs, including hazard identification, evaluation, and control, accident/injury prevention, hazardous materials/waste management, emergency preparedness, fire/life safety, ergonomics, industrial hygiene, and environmental regulatory compliance.

This role spans both a GMP pharmaceutical manufacturing environment and a pharmaceutical R&D laboratory environment and is expected to fulfill all EHS operational responsibilities independently and without direct supervision at each site. The Manager EHS is a Subject Matter Expert (SME) with demonstrated advanced knowledge of environmental health & safety practices and procedures, responsible for conducting all Material Risk Assessments for compounds used at MedPharm US facilities.

Responsibilities

  • Develop and maintain appropriate EH&S policies and procedures in compliance with State, Federal, and Local regulatory requirements and company standards.
  • Implement EHS programs and procedures that align with company requirements and assess their impact on affected areas.
  • Perform tasks within multiple disciplines of the EHS department as needed and escalate compliance concerns to the management team based on risk exposure.
  • Analyze data for regulatory compliance, including trending and presentation in management reviews.
  • Coordinate and conduct employee training in EH&S programs.
  • Conduct safety inspections and audits, correlating data from inspections with current injury trends.
  • Develop and manage an effective Emergency Response Program, including leading an Emergency Response Team.
  • Coordinate the Occupational Health and Ergonomics Programs.
  • Act as the primary contact for regulators at the sites and follow appropriate escalation procedures.
  • Lead the Material Risk Assessment program for all new compounds brought into any of the US sites prior to entering the facilities and train individuals on safety aspects for handling these compounds.
  • Provide record keeping necessary to maintain compliance with all local, state, and Federal standards.
  • Define, report, and achieve all EHS targets and KPIs.
  • Lead other professionals and management in the application of standard EHS theories, concepts, and techniques.
  • Initiate and cultivate open, professional relationships with stakeholders by establishing rapport and understanding others' needs and common goals.
  • Oversee the implementation of accident/incident investigation and corrective actions.
  • Ensure all EH&S training documentation is maintained and readily retrievable for client audits and regulatory agency inspections.
  • Guide the incident response team and Site Safety Committee.
  • Lead the site’s Hazardous Waste program and activities, and manage the introduction of new chemicals to the facility.
  • Promote and sustain a safety culture, striving to be recognized as an industry leader.
  • Lead regular site audits and risk assessment activities to ensure company and regulatory compliance; track and manage on-time implementation of corrective actions identified during audits or risk assessments.
  • Engage other department leaders to develop and maintain safety training programs in all applicable areas, ensuring training is appropriately documented, regularly reviewed, and compliant.

R&D Site Laboratory and Facility EHS Operations (RTP Site)

  • Independently manage the disposal of experimental compounds and study samples, including documentation of chain-of-custody and client-specific destruction requirements.
  • Conduct routine daily and weekly waste management tasks, including biohazard waste pickups, chemical waste container management, broken glassware disposal, and collection of oil waste.
  • Perform routine safety and equipment inspections internally and coordinate scheduled preventive maintenance and testing with qualified external vendors.
  • Conduct routine eyewash and spill station checks and coordinate annual preventive maintenance on emergency eyewash and safety shower systems.
  • Manage the site pest control program, including coordination with licensed vendors and documentation of service records.
  • Administer the Bloodborne Pathogen program, including exposure control plan maintenance, training coordination, and post-exposure follow-up procedures.
  • Plan, coordinate, and deliver EHS annual training programs for site personnel, ensuring all required curricula are completed, documented, and retrievable for audits.
  • Maintain and renew the site’s Controlled Substance License in compliance with DEA and applicable state requirements, including recordkeeping, inventory reconciliation, and reporting obligations.
  • Coordinate and support the annual fire safety inspection process, including scheduling, preparation of documentation, and closure of findings.
  • Prepare and submit all required OSHA year-end documentation, including OSHA 300, 300A, and 301 logs, and support related regulatory inquiries or inspections.
  • Author, review, and maintain EHS-related SOPs and supporting documents within the site quality management system.
  • Support client audits and regulatory inspections by ensuring EHS documentation, training records, waste manifests, and inspection logs are current, organized, and retrievable.

Requirements

  • Master's or bachelor's degree in EHS, Occupational Health, Engineering, Science, or a closely related discipline is desired, or equivalent technical experience plus demonstrated competence.
  • Minimum of 7 years of EHS-related experience within pharmaceutical manufacturing or R&D environments.
  • Demonstrated experience in implementing EHS regulations, conducting incident investigations, and interacting with regulatory agencies and external organizations.
  • Experience in Risk Assessments & Job Hazard Analysis for pharmaceuticals.
  • Experience with DEA Controlled Substance license administration and compliance, including Schedule I through V compounds in a pharmaceutical research and manufacturing setting.
  • Familiarity with SOP authorship, change control systems, and document management practices as they apply to EHS program administration in a pharmaceutical CRO or R&D setting.
  • Demonstrated success in independent judgment, technical proficiency, scientific creativity, and collaboration with others in a cGMP environment.
  • Effective knowledge of applicable federal, state, and local regulations.
  • Familiarity with industry standards, such as NFPA, ANSI, ACGIH, ISO, NIOSH, ASME.
  • Familiarity with RCRA, CAA, CWA, NRC, EPA, DEP, and Residual Waste Regulations.
  • Certification in Safety (CSP), Industrial Hygiene (CIH), and/or Hazardous Materials Manager (CHMM) is a plus.

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