GMP EHS Specialist – Cleanroom & Regulatory Compliance

integralife

Braintree (MA)

On-site

USD 71,000 - 98,000

Full time

5 days ago
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Job summary

Integra LifeSciences seeks an EHS Specialist to develop and sustain programs ensuring compliance with OSHA, FDA, EPA, and ISO standards within a GMP cleanroom manufacturing setting.

The role partners with Facilities, Manufacturing, Quality, and Engineering to integrate safety and environmental controls into daily operations, driving proactive risk management and continuous improvement for product quality and employee wellbeing.

Qualifications

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

Responsibilities

  • Develop and maintain EHS programs for ISO-classified cleanrooms (ISO 7/8).
  • Ensure OSHA, FDA cGMP, ISO 13485/14644 compliance and regulatory readiness.
  • Partner with Quality to align EHS with validated processes and change control.

Skills

Hazard identification
Incident investigation
Cross-functional collaboration
Regulatory knowledge
Training delivery

Education

Bachelor’s degree in Environmental Health & Safety, Industrial Hygiene, Environmental Science, or related field

Tools

SDS management
Environmental monitoring programs
HVAC/HEPA systems

Job description

Integra LifeSciences seeks an EHS Specialist to develop and sustain programs ensuring compliance with OSHA, FDA, EPA, and ISO standards within a GMP cleanroom manufacturing setting.

The role partners with Facilities, Manufacturing, Quality, and Engineering to integrate safety and environmental controls into daily operations, driving proactive risk management and continuous improvement for product quality and employee wellbeing.

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