Lead Specialist, Sterilization and Microbiology - Exton, PA

DSM
United States
Workplace: OnsiteFull timeUSD 66,000 - 90,000 annuallyFunction: Administration & Executive AssistanceExperience: 3-5 yearsEducation: bachelorsSkills: ["Communication","Problem-solving","Documentation","Attention to detail","Teamwork"]

Lead Specialist responsible for sterilization activities and microbiology controls at Exton, supporting QA/QC, environmental monitoring, supplier compliance, and viral safety assessments. Plays a key role in validating sterilization methods, ensuring regulatory adherence (ISO13485, GMP, FDA), and coordinating with internal labs and external facilities to maintain product safety and quality across Biomedical manufacturing operations.

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DSM
DSM
5 months ago

Lead Specialist, Sterilization and Microbiology - Exton, PA

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Last checked: 15 hours agoStatus: Live

Job Summary

Lead Specialist responsible for sterilization activities and microbiology controls at Exton, supporting QA/QC, environmental monitoring, supplier compliance, and viral safety assessments. Plays a key role in validating sterilization methods, ensuring regulatory adherence (ISO13485, GMP, FDA), and coordinating with internal labs and external facilities to maintain product safety and quality across Biomedical manufacturing operations.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Administration & Executive Assistance

Key Responsibilities

  • •Support sterilization activities on products manufactured at site, including dose audits and EO requalification assessments
  • •Manage internal and sub-contracted testing programs for patient safety including sterile product release and contamination control
  • •Serve as liaison to internal and external laboratory testing functions and audit contract facilities to international/regulatory standards (ISO 13485)
  • •Support supplier compliance to sterilization sciences and biosafety systems; author and review validations and product adoptions
  • •Oversee Environmental Monitoring Program and Controlled Environment qualification activities; ensure adherence to policies and procedures

Pay and Benefits

Salary: USD 66,000 - 90,000 annually
Perks:Health Insurance

Key Requirements

  • •Bachelor’s degree in Biological science with experience within the medical device/pharmaceutical industry
  • •3-5 years experience in QA/QC, preferably within the scope of microbiological control in Medical Device/Pharmaceutical Manufacturing
  • •Sterilization experience (gamma, Ebeam, EtO) required
  • •Environmental monitoring experience preferred
  • •Knowledge of ISO13485 & MDD; Advanced understanding of cGMP, ISO, USP, AAMI standards
Experience:3-5 yearsMedical devicePharmaceuticalBiomedicalSterilizationQuality assuranceEnvironmental monitoring
Education:Bachelor's in Biological sciences
Skills:CommunicationProblem-solvingDocumentationAttention to detailTeamwork
Languages:English
Tech Stack:ISO13485GMPFDA 21 CFR 820SAPMicrosoft OfficeDocument Management SystemsEO sterilizationGammaEbeamEtOBioburdenEndotoxinEnvironmental monitoringCGMPUSPAAMI

Company Brief

DSM
DSM-Firmenich is a global leader in food ingredients, nutrition, fragrances and beauty solutions, formed by the merger of DSM and Firmenich to provide sustainable, science-driven products and services across food, health and personal care industries.
Industry: Chemical Manufacturing
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Established Company
Headquarters: Geneva, Switzerland
Founded: 2023
WebsiteLinkedIn