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Role: Microbiologist/Sterilization (Day one onsite)
Location: Brooklyn Park, MN
Job type: Contract
Job Description:
Industry: Regulatory, Medical devices,
Companies: Medtronic, Stryker, Zimmer, Johnson & Johnson, GE(Medical Device), Phillips (Medical Device), Baxter, Abbott
5-7 years of relevant experience
Master's degree in a scientific discipline (Microbiology/Bio-Technology/ Science/ Pharmacy) with relevant experience in sterilization validation or equivalent
Must to have:OECD, FDA GLP, GMP, ISO 10993 series, ISO 17025, USP pharmacopeia
Adds Value:European Medical Device Regulation
The candidate should have knowledge of microbiology and sterilization techniques for medical devices (EO and Radiation gamma preferably), also general Quality Management System knowledge
Prefer experience with Sterilization Validation / Microbiology methods validation, Global sterilization regulations & TQM methods
ISO 13485 experience preferred Knowledge, Skills, & Abilities
Technical writing skills, remote support for projects, strong interpersonal skills, and with a quick adaptive mindset for new technologies.
Functional knowledge of Design Controls and Industry standards in Packaging Design and Testing (11607, ASTM, ISTA)
Strong problem-solving skills across a broad range of complexities.
1. Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies supporting medical devices
2. Perform standard sterilization engineering assignments for application, validity, and conformance to specifications
3. Analysis and evaluation of sterilization studies data and assist in preparing documentation using Good Documentation Practices (GDP)
4. Support with coordination and development activities for terminal sterilization methods (ethylene oxide, gamma/E-Beam irradiation)
5. Ensure compliance with quality system and sterilization standards requirements ISO 13485, ISO 11135, and ISO 11137; DMR and ECN per 21CFR 820, ISO 14971
6. Lead and ensure validation actions comply with all international sterilization standards and meet all regulatory compliance requirements for sterile products
7. Work with cross-functional teams to develop, test, validate, and commercialize package solutions / Medical devices for new and existing products
8. Developing, reviewing, and approving the packaging documents: packaging component specifications, packaging component drawings, design history files, and risk/criticality assessments.
9. Sealing process characterization study based on ISO 11607
10. Lead Microbiology lab for Test method validation for Pyrogen Testing as per USP Standards
11. Strong operations professional skilled in Validation, Packaging, Sterilization, and Cleanroom Operations. Knowledge in DMR, DHR, PFMEA, CAPA, and FDA inspection
12. Coordinate and manage testing activities with contract laboratories
Regards,
Sanjay Singh
Delivery Manager
O: +1 217 374 4070
Email: sanjay.singh@trioptus.com | Web: (link removed)
United States | Canada | India
Trioptus
