Sterilization Specialist

Merrimack Manufacturing•Manchester, NH

3d•Hybrid

About The Position

Merrimack Manufacturing is seeking a Sterilization Specialist to support and maintain the sterilization program for gamma and EO sterilized medical devices. This role acts as the internal subject matter expert for sterilization processes, validation, documentation, data interpretation, and regulatory compliance, ensuring adherence to ISO 11137, ISO 13485, FDA requirements, and internal procedures. The Specialist will collaborate with various departments and external vendors to ensure product safety and sterility assurance.

Requirements

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.
Working knowledge of ISO 11137 standards, Gamma irradiation sterilization processes, Sterility Assurance Level (SAL) concepts, Bioburden and dose validation methodologies, and 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).

Nice To Haves

Sterilization or microbiology training/certification
Auditor training (ISO 13485 or supplier auditing)

Responsibilities

Serve as the internal technical expert for gamma sterilization processes and sterilization-related quality systems.
Manage and maintain sterilization program documentation, procedures, protocols, and records.
Ensure compliance with ISO 11137, ISO 13485, FDA 21 CFR Part 820 QSR, and applicable GMP requirements.
Coordinate sterilization activities with external contract sterilization providers.
Support sterilization validation activities including dose audits, dose mapping, bioburden testing, sterility testing, verification dose experiments, product family assessments, and packaging/material compatibility evaluations.
Review and interpret sterilization cycle data, dosimetry reports, validation studies, and laboratory results.
Evaluate the impact of changes on validated sterilization parameters.
Support implementation and maintenance of sterilization validation strategies and SAL requirements.
Participate in product and process development to ensure sterilization compatibility.
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.
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.
Support supplier qualification and ongoing supplier performance monitoring activities.