Sterilisation Manager

Collins McNicholas Recruitment; Munster; On-site; EUR 80,000 - 95,000; Full time

Job summary

Join a leading global medical device organisation as a Sterilisation Manager. This role involves ensuring compliance with sterilisation regulations and leading a team focused on product qualification and validation processes. Ideal candidates will have extensive experience in sterilisation modalities and strong problem-solving skills, working within a quality-regulated environment.

Qualifications

• Minimum 9 years' related experience or equivalent education.
• Strong expertise in at least one sterilisation modality.
• Proven experience in sterilisation validation and compliance.

Responsibilities

• Lead team responsible for sterilisation qualifications.
• Oversee validation processes for sterilised products.
• Manage investigations of dose audit failures.

Skills

Sterilisation expertise

Team leadership

Problem solving

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in a relevant discipline

Advanced degree preferred

Job description

This role is within a leading global medical device organisation focused on advancing the treatment of vascular disease. The Sterilisation Manager is responsible for ensuring all sterilisation activities are compliant with relevant corporate and divisional policies, procedures, and regulatory requirements.

Key Responsibilities:

• Lead a team responsible for sterilisation qualifications related to new product introductions and changes to existing products.

• Oversee validation processes for radiation-sterilised products, including dose setting and routine quarterly audits.

• Direct validations for ethylene oxide (EO)-sterilised products, including new product qualifications, annual revalidations, EO residual studies, and D-value studies.

• Provide sterilisation subject matter expertise to support Product Development and Operations teams.

• Support Supplier Quality in auditing contract sterilisation providers and third-party manufacturers.

• Manage investigations of dose audit failures and EO biological indicator sterility positives.

Education & Experience:

• Bachelor’s degree in a relevant discipline with a minimum of 9 years’ related experience, or an equivalent combination of education and experience. An advanced degree is preferred.

• Strong expertise in at least one sterilisation modality, such as Radiation or Ethylene Oxide.

• Proven experience leading technical teams in sterilisation validation, troubleshooting, and compliance within a quality-regulated environment.

• Demonstrated ability to solve complex problems requiring deep analysis and cross-functional collaboration.

• In-depth knowledge of industry practices, regulations, and potential technical alternatives and their business impact.

For a confidential discussionandmore information on the role,please contactKevin Griffin.

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