EHS Specialist

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Develop and maintain EHS programs specific to ISO‑classified cleanroom environments (ISO7/8). Evaluate safety risks while ensuring they do not compromise product sterility or cleanroom integrity.

• Ensure compliance with OSHA (29 CFR
  1910), FDA cGMP requirements (21
  
  CFRPart
  820), ISO
  13485 & ISO
  14644 cleanroom standards, EPA and MassDEP environmental regulations.
• Partner with Quality to ensure EHS programs align with validated processes, change control, and audit readiness.
• Support internal, customer, and regulatory audits, including FDA inspections.

• Manage chemicals used in cleanroom environments (e.g., disinfectants, solvents, sterilants).
• Ensure compliance with cleanroom‑compatible chemical handling, labeling, and storage requirements.
• Oversee hazardous waste segregation and disposal, ensuring no cross‑contamination risks.
• Maintain Safety Data Sheets (SDS) and ensure compatibility with clean manufacturing processes.

• Partner with consulting firms on industrial hygiene assessments related to airborne contaminants, cleanroom disinfectants and chemical exposure, ventilation effectiveness (HEPA systems awareness).
• Ensure safe interaction with HVAC systems, HEPA filtration, and pressurization controls.

• Perform Job Hazard Analyses (JHAs) tailored to cleanroom tasks (e.g., assembly, inspection, sterilization prep).
• Evaluate ergonomic risks associated with repetitive motion under cleanroom constraints, extended gowning periods.
• Lead incident investigations with a focus on personnel safety and potential product impact (non‑conformance linkage).

• Develop and deliver EHS training integrated with chemical safety in controlled environments and emergency response in cleanroom settings.
• Reinforce human performance and contamination control behaviors (movement, material handling, PPE compliance).
• Collaborate with Quality to ensure training supports GMP compliance and documentation requirements.

• Develop emergency procedures that account for cleanroom constraints, including controlled evacuation protocols, chemical spill response inside clean rooms, fire safety without compromising product safety.
• Serve on the Emergency Response Team (ERT) with training in cleanroom shutdown procedures.
• Coordinate with Facilities for HVAC isolation if needed, and document responses.

• Maintain EHS documentation in compliance with GMP document control standards.
• Track and trend safety metrics (TRIR, near misses), environmental data, and cleanroom‑related incidents.
• Drive continuous improvement initiatives that balance safety compliance and product quality.

Education & Experience

• Bachelor’s degree in Environmental Health & Safety, Industrial Hygiene, Environmental Science, or related field.
• 2–5 years of EHS experience in cleanroom manufacturing (medical device, pharma, biotech preferred).
• Experience working in GMP/FDA‑regulated environments required.

Technical Knowledge

• Strong understanding of OSHA safety regulations, MassDEP hazardous waste regulations, MWRA wastewater permitting requirements, chemical hygiene in controlled environments.
• Familiarity with environmental monitoring programs, HVAC/HEPA systems, and cleanroom pressurization concepts, pH neutralization wastewater systems.

Skills

• Ability to balance safety requirements with strict contamination control standards.
• Strong cross‑functional collaboration with Quality and Manufacturing teams.
• Effective incident investigation and root cause analysis.
• Clear communication and training delivery in regulated environments.
• Actively support Safety Committee goals and objectives.

Certifications (Preferred)

• OSHA 30‑hour certification
• RCRA/DOT

Working Conditions

• Regular work within ISO‑classified clean rooms requiring full gowning.
• Exposure to disinfectants and other chemical agents; controlled temperature and humidity environments.
• Must follow strict gowning, hygiene, and behavioral protocols.
• Occasional off‑shift support for manufacturing or environmental monitoring activities.

• Zero significant EHS‑related audit findings.
• Reduction in safety incidents without impacting product quality.