Sterilization Specialist

Company Overview:
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.

Position Summary

The Sterilization Specialist is responsible for supporting and maintaining the sterilization program for gamma and EO sterilized medical devices manufactured under an ISO 13485 quality management system. Although sterilization processing is performed by an external contract sterilization provider, this role serves as the internal subject matter expert for sterilization processes, validation activities, technical documentation, data interpretation, and regulatory compliance.

The Sterilization Specialist ensures that sterilization activities comply with applicable regulatory and industry standards, including ISO 11137, ISO 13485, FDA requirements, and internal quality procedures. This role collaborates cross-functionally with Quality, Regulatory, Manufacturing, R&D, Supply Chain, and external sterilization vendors to support product safety, sterility assurance, and product release activities.

Responsibilities
Sterilization Program Management

• 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 – Sterilization of health care products – Radiation
  • ISO 13485 Quality Management System requirements
  • FDA 21 CFR Part 820 Quality System Regulation (QSR)
  • Applicable GMP requirements
• 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.