| Microbiologist | Sterilization Consultant Location: Brooklyn Park, MN at Brooklyn, New York, USA |
| Email: [email protected] |
| From: David Johnson, concord it systems [email protected] Reply to: [email protected] Role: Microbiologist | Sterilization Consultant Location: Brooklyn Park, MN Job Description: Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies supporting medical devices Perform standard sterilization engineering assignments for application, validity, and conformance to specifications Analysis and evaluation of sterilization studies data and assist in preparing documentation using Good Documentation Practices (GDP) Support with coordination and development activities for terminal sterilization methods (ethylene oxide, gamma/E-Beam irradiation) Ensure compliance with quality system and sterilization standards requirements ISO 13485, ISO 11135, and ISO 11137; DMR and ECN per 21CFR 820, ISO 14971 Lead and ensure validation actions comply with all international sterilization standards and meet all regulatory compliance requirements for sterile products Work with cross-functional teams to develop, test, validate, and commercialize package solutions / Medical devices for new and existing products Developing, reviewing, and approving the packaging documents: packaging component specifications, packaging component drawings, design history files, and risk/criticality assessments. Sealing process characterization study based on ISO 11607 Lead Microbiology lab for Test method validation for Pyrogen Testing as per USP Standards Strong operations professional skilled in Validation, Packaging, Sterilization, and Cleanroom Operations. Knowledge in DMR, DHR, PFMEA, CAPA, and FDA inspection Coordinate and manage testing activities with contract laboratories Required Skills: 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. Must to have: OECD, FDA GLP, GMP, ISO 10993 series, ISO 17025, USP pharmacopeia Adds Value: European Medical Device Regulation Education: Masters degree in a scientific discipline (Microbiology/Bio-Technology/ Science/ Pharmacy) with relevant experience in sterilization validation or equivalent Thanks & Regards David Johnson Sr.IT Recruiter Desk Number: +1 209 706 0814 Concord Id :[email protected] Concord IT Systems, Inc - Project & Staffing Solutions (https://concorditsystems.com) Keywords: information technology Idaho Minnesota |
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| Wed Aug 02 18:38:00 UTC 2023 |