Environmental Monitoring Technician
Indivior
6 hours ago
On-site
Raleigh, NC
Operations
Position Summary
- Perform routine environmental monitoring to assess viable and nonviable particulate levels within classified manufacturing rooms and support rooms.
Responsibilities (Essential Functions)
- Conduct viable/nonviable environmental monitoring throughout the facility, including aseptic processing areas and classified manufacturing areas (Compounding, Component Preparation, Vial Wash, Dispensary).
- Collect facility waters, submit for testing, accurately record results, and promptly report discrepancies or out-of-limit conditions to supervisor.
- Perform aseptic gowning training and certification sampling.
- Requisition materials, maintain inventory, and receive/store prepared media.
- Prepare environmental monitoring plates and EM test reports for aseptic processing areas.
- Disinfect incubator rooms weekly.
- Follow safety requirements and maintain good housekeeping of the laboratory area.
- Incubate and inspect media fill units; incubate and examine samples for microbial growth.
- Enumerate bacteria and report excursions.
- Maintain temperature charts for incubators and refrigerators in the Microbiology Laboratory.
- Ensure processes/products comply with local, state, and federal rules; support cGMP compliance and understand regulatory requirements (e.g., 21 CFR Parts 210/211, FDA, OSHA).
Minimum Qualifications
- Bachelor’s degree in Chemistry, Microbiology, Biology, or related Science (accredited university).
- OR Associate’s degree + 3+ years in pharmaceutical industry (cGMP environment) and aseptic technique.
- OR High School Diploma + 5+ years in pharmaceutical industry (cGMP environment) and aseptic technique.
- 1+ year experience in pharmaceutical industry (cGMP environment) and aseptic technique.
- Ability to get gowning certified within 30 days.
- Physical ability: stand/walk up to 8 hours (4 hours at a time in aseptic processing), lift/move up to 35 lbs, reach with hands/arms up to 6 hours; climb/balance/stoop/kneel/crouch/crawl up to 1 hour.
- Flexible to work across shifts (nights and/or weekends) as needed.
Competencies/Conduct
- “See it, Own it, Make it Happen” attitude.
- Excellent problem solving and critical thinking; strong attention to detail and ability to follow standard procedures.
- Team collaboration, professional behavior, and good interpersonal/communication skills.
Benefits (as listed)
- 3 weeks’ vacation plus floating holidays and sick leave.
- 401(k) with company match (75% on first 6% contributions) and profit sharing contribution (equal to 4% of eligible pay).
- U.S. Employee Stock Purchase Plan (15% discount).
- Comprehensive Medical, Dental, Vision, Life and Disability coverage.
- Health/Dependent Care Limited Purpose Flex Spending and HSA options.
- Adoption assistance; tuition reimbursement.
- Concierge/personal assistance services.
- Voluntary benefits (Legal, Pet Insurance, Critical Illness).
- Gym/fitness facility and cell phone discounts.
- Perform routine environmental monitoring to assess viable and nonviable particulate levels within classified manufacturing rooms and support rooms.
Responsibilities (Essential Functions)
- Conduct viable/nonviable environmental monitoring throughout the facility, including aseptic processing areas and classified manufacturing areas (Compounding, Component Preparation, Vial Wash, Dispensary).
- Collect facility waters, submit for testing, accurately record results, and promptly report discrepancies or out-of-limit conditions to supervisor.
- Perform aseptic gowning training and certification sampling.
- Requisition materials, maintain inventory, and receive/store prepared media.
- Prepare environmental monitoring plates and EM test reports for aseptic processing areas.
- Disinfect incubator rooms weekly.
- Follow safety requirements and maintain good housekeeping of the laboratory area.
- Incubate and inspect media fill units; incubate and examine samples for microbial growth.
- Enumerate bacteria and report excursions.
- Maintain temperature charts for incubators and refrigerators in the Microbiology Laboratory.
- Ensure processes/products comply with local, state, and federal rules; support cGMP compliance and understand regulatory requirements (e.g., 21 CFR Parts 210/211, FDA, OSHA).
Minimum Qualifications
- Bachelor’s degree in Chemistry, Microbiology, Biology, or related Science (accredited university).
- OR Associate’s degree + 3+ years in pharmaceutical industry (cGMP environment) and aseptic technique.
- OR High School Diploma + 5+ years in pharmaceutical industry (cGMP environment) and aseptic technique.
- 1+ year experience in pharmaceutical industry (cGMP environment) and aseptic technique.
- Ability to get gowning certified within 30 days.
- Physical ability: stand/walk up to 8 hours (4 hours at a time in aseptic processing), lift/move up to 35 lbs, reach with hands/arms up to 6 hours; climb/balance/stoop/kneel/crouch/crawl up to 1 hour.
- Flexible to work across shifts (nights and/or weekends) as needed.
Competencies/Conduct
- “See it, Own it, Make it Happen” attitude.
- Excellent problem solving and critical thinking; strong attention to detail and ability to follow standard procedures.
- Team collaboration, professional behavior, and good interpersonal/communication skills.
Benefits (as listed)
- 3 weeks’ vacation plus floating holidays and sick leave.
- 401(k) with company match (75% on first 6% contributions) and profit sharing contribution (equal to 4% of eligible pay).
- U.S. Employee Stock Purchase Plan (15% discount).
- Comprehensive Medical, Dental, Vision, Life and Disability coverage.
- Health/Dependent Care Limited Purpose Flex Spending and HSA options.
- Adoption assistance; tuition reimbursement.
- Concierge/personal assistance services.
- Voluntary benefits (Legal, Pet Insurance, Critical Illness).
- Gym/fitness facility and cell phone discounts.