Sterilization Specialist
Merrimack Manufacturing
- Manchester, New Hampshire, United States
- Manchester, New Hampshire, United States
About
Coordinate sterilization activities with external contract sterilization providers. Validation & Technical Support Support sterilization validation activities including: Dose audits Dose mapping Bioburden testing Sterility testing Verification dose experiments Product family assessments Packaging and material compatibility evaluations
Review and interpret sterilization cycle data, dosimetry reports, validation studies, and laboratory results. Evaluate the impact of product, packaging, material, or process changes on validated sterilization parameters. Support implementation and maintenance of sterilization validation strategies and SAL (Sterility Assurance Level) requirements. Participate in product and process development activities to ensure sterilization compatibility. Quality & Compliance Review and approve sterilization records and documentation for product release support. Support investigations involving sterilization deviations, nonconformances, excursions, and CAPA activities. Perform trend analysis of sterilization and bioburden data. Assist with internal audits, supplier audits, customer audits, and regulatory inspections. Ensure sterilization records are audit-ready and maintained per document control requirements. Collaborate with Regulatory Affairs to support submissions and regulatory documentation related to sterilization. Supplier & Cross-Functional Collaboration Serve as primary liaison with contract sterilization vendors and testing laboratories. Coordinate shipment schedules, sterilization processing timelines, and documentation exchange. Work closely with Manufacturing, Supply Chain, R&D, Packaging Engineering, and Quality teams to support production and validation activities. Support supplier qualification and ongoing supplier performance monitoring activities. Qualifications Education & Experience Bachelor’s degree in Engineering, Microbiology, Biology, Chemistry, Life Sciences, or related technical field preferred. 3–5 years of experience in medical device, pharmaceutical, biotechnology, or regulated manufacturing environments. Experience with gamma sterilization and sterilization validation activities preferred. Familiarity with outsourced sterilization operations and external sterilization suppliers strongly preferred. Experience working within ISO 13485 and FDA-regulated environments. Knowledge, Skills, and Abilities Working knowledge of: ISO 11137 standards Gamma irradiation sterilization processes Sterility Assurance Level (SAL) concepts Bioburden and dose validation methodologies FDA Quality System Regulation requirements
Ability to interpret technical sterilization data, validation reports, and laboratory results. Strong analytical, problem-solving, and technical writing skills. Knowledge of validation principles, statistical sampling, and risk management preferred. Excellent communication and cross-functional collaboration skills. Strong organizational skills with attention to detail and documentation accuracy. Proficient in Microsoft Office and electronic quality management systems (eQMS). Preferred Certifications (Optional) Sterilization or microbiology training/certification Auditor training (ISO 13485 or supplier auditing) Physical Requirements Ability to work in office, laboratory, and manufacturing environments as needed. Occasional travel to sterilization vendors, testing laboratories, or suppliers may be required.
Languages
- English
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