EHS Specialist

Environmental Health & Safety SpecialistJoining 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.The Environmental Health & Safety (EHS) Specialist is responsible for developing, implementing, and maintaining programs that ensure compliance with federal, state, and local environmental, health, and safety regulations. This role supports a medical device manufacturing environment by promoting a strong safety culture, minimizing workplace risks, and ensuring adherence to OSHA, EPA, and other applicable standards.The EHS Specialist is a key member of the Braintree site's Environmental, Health & Safety (EHS) function, supporting a regulated medical device manufacturing environment. This role is responsible for implementing and sustaining programs that ensure compliance with federal, state, and local regulations, while promoting a culture of safety and environmental stewardship across the site.Operating within a GMP-regulated environment, the EHS Specialist partners closely with Facilities, Manufacturing, Quality, and Engineering to ensure that safety and environmental controls are effectively integrated into daily operations. The role directly supports compliance with OSHA standards, EPA regulations, FDA expectations, and ISO 14001/45001 frameworks (as applicable), recognizing that EHS performance is closely tied to product quality, operational continuity, and employee wellbeing.The position serves as a technical resource and advisor to site leadership and functional teams, providing guidance on hazard identification, risk mitigation, and regulatory requirements. The EHS Specialist is responsible for driving proactive risk management, ensuring workplace hazards are identified, assessed, and controlled before incidents occur.The EHS Specialist partners with operations, facilities, engineering, and leadership teams to proactively identify hazards, reduce environmental impact, and improve overall workplace safety and compliance performance.Key ResponsibilitiesCleanroom Safety & Contamination ControlDevelop 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.Regulatory Compliance & Quality IntegrationEnsure compliance with:OSHA (29 CFR 1910)FDA cGMP requirements (21 CFR Part 820)ISO 13485 & ISO 14644 cleanroom standardsEPA and MassDEP environmental regulationsPartner with Quality to ensure EHS programs align with validated processes, change control, and audit readiness.Support internal, customer, and regulatory audits, including FDA inspections.Chemical & Hazardous Material ManagementManage chemicals used in cleanroom environments (e.g., disinfectants, solvents, and 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.Environmental Monitoring & Industrial HygienePartner with consulting firms on industrial hygiene assessments related to:Airborne contaminantsCleanroom disinfectants and chemical exposureVentilation effectiveness (HEPA systems awareness)Ensure safe interaction with HVAC systems, HEPA filtration, and pressurization controls.Safety Risk Management in Controlled EnvironmentsPerform Job Hazard Analyses (JHAs) tailored to cleanroom tasks (e.g., assembly, inspection, sterilization prep).Evaluate ergonomic risks associated with:Repetitive motion under cleanroom constraintsExtended gowning periodsLead incident investigations with a focus on both:Personnel safetyPotential product impact (non-conformance linkage)Training & Cleanroom Behavior ComplianceDevelop and deliver EHS training integrated with:Chemical safety in controlled environmentsEmergency response in cleanroom settingsReinforce human performance and contamination control behaviors (movement, material handling, PPE compliance).Collaborate with Quality to ensure training supports GMP compliance and documentation requirements.Emergency Preparedness & Response (Cleanroom-Specific)Develop emergency procedures that account for cleanroom constraints, including:Controlled evacuation protocolsChemical spill response inside cleanroomsFire safety without compromising product safetyServe on the Emergency Response Team (ERT) with training in:Cleanroom shutdown proceduresCoordination with Facilities for HVAC isolation if neededDocumentation & Continuous ImprovementMaintain EHS documentation in compliance with GMP document control standards.Track and trend:Safety metrics (TRIR, near misses)Environmental dataCleanroom-related incidentsDrive continuous improvement initiatives that balance:SafetyComplianceProduct qualityQualificationsEducation & ExperienceBachelor'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 KnowledgeStrong understanding of:OSHA safety regulationsMassDEP hazardous waste regulationsMWRA wastewater permitting requirementsChemical hygiene in controlled environmentsFamiliarity with:Environmental monitoring programsHVAC/HEPA systems and cleanroom pressurization conceptspH neutralization wastewater systemsSkillsAbility to balance safety requirements with strict contamination control standardsStrong cross-functional collaboration with Quality and Manufacturing teamsEffective incident investigation and root cause analysisClear communication and training delivery in regulated environmentsActively support Safety Committee goals and objectivesCertifications (Preferred)OSHA 30-hour certificationRCRA/DOTWorking ConditionsRegular work within ISO-classified cleanrooms requiring full gowningExposure to:Disinfectants and other chemical agentsControlled temperature and humidity environmentsMust follow strict gowning, hygiene, and behavioral protocolsOccasional off-shift support for manufacturing or environmental monitoring activitiesSuccess MeasuresZero significant EHS-related audit findingsReduction in safety incidents without impacting product qualityHigh compliance with cleanroom gowning and safety proceduresSuccessful integration of EHS