EHS Specialist
About the role
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.
Responsibilities
Develop and maintain EHS programs specific to ISO-classified cleanroom environments (ISO 7/8).
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 CFR Part 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, and sterilants).
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.
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 cleanrooms, fire safety without compromising product safety.
Serve on the Emergency Response Team (ERT) with training in: cleanroom shutdown procedures, coordination with Facilities for HVAC isolation if needed.
Maintain EHS documentation in compliance with GMP document control standards.
Track and trend: safety metrics (TRIR, near misses), environmental data, cleanroom-related incidents.
Drive continuous improvement initiatives that balance: safety, compliance, product quality.
Develop and deliver EHS training integrated with: chemical safety in controlled environments, emergency response in cleanroom settings, reinforcement of human performance and contamination control behaviors (movement, material handling, PPE compliance).
Collaborate with Quality to ensure training supports GMP compliance and documentation requirements.
Support Safety Committee goals and objectives.
Qualifications
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.
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.
Benefits
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Pay
Pay Range: $71,300.00 - $97,750.00 USD
Schedule
Regular work within ISO-classified cleanrooms requiring full gowning.
Additional Description for Pay Transparency
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition.