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Senior Scientist, Microbiological Quality & Sterility Assurance
Ethylene Oxide Sterilizers, Validation, Aseptic Processing, Microbiology
Job
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.For our client Johnson & Johnson MedTech - Vision we are searching for a Senior Scientist, Microbiological Quality & Sterility Assurance.
Keywords
- Ethylene Oxide Sterilizers (EtO Sterilizers)
- Microbiological Quality
- Sterility Assurance
- Sterilization Validation
- Aseptic Processing
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In the context of New Product Introductions (NPI), you serve as a core team member, contributing to modality selection, protocol and report writing, and regulatory submission support. You lead on-site validation activities at new contract sterilization sites and collaborate with R&D to define packaging requirements, evaluate sterilization impacts on product biocompatibility, and drive sterility assurance strategy throughout the product lifecycle.
You provide expert input into quality agreements for sterilization contracts, contract laboratories, and external manufacturers. Where needed, you conduct site audits, support corrective actions, and contribute to regulatory readiness programmes including internal and external audit visits. You maintain an active presence at manufacturing sites to assess sterility risks, support revalidation activities, and drive remediation where required.
Your technical ownership covers sterilization validation (EO, gamma, electron beam, moist heat, dry heat), aseptic processing validation, microbiological testing including bioburden and BET, environmental monitoring, water system validation, cleanroom management, and regulatory and inspection support including health-based risk assessments.
Externally, you represent Johnson & Johnson at industry standards bodies such as AAMI and ISO. Internally, you develop and implement training programmes to build MQSA competencies across the organisation and contribute to cross-functional initiatives focused on design for value and manufacturability.
Profile
You hold an MSc or PhD in Microbiology, Biology, Engineering, or a related discipline, combined with at least 8 years of experience in the medical device or pharmaceutical industry within a GMP and/or ISO regulated environment.- Extensive knowledge of sterilization methodologies (gas, heat, radiation) and aseptic processing
- Proven track record in troubleshooting microbiological and sterilization issues with effective CAPA implementation
- Experience interacting with regulatory authorities and representing organisations at industry associations
- Strong communication and stakeholder management skills, with a collaborative and customer-focused mindset
Benefits
Contract for 6 months, with intention to make it a permanent position.This role requires a minimum of three days per week on-site and involves some travel to other manufacturing sites and external manufacturers (about 2-4 times/year).
Salary: >64.000 gross/year
Days of leave: 36 per year.
See here our other employment terms for this vacancy
Company profile
Johnson & Johnson Vision combines science, technology, and people to help preserve and restore sight worldwide. Partnering with eye care professionals, the organisation delivers a broad portfolio of solutions including ACUVUE® contact lenses, consumer eye health products, dry eye treatments, refractive (LASIK), and cataract solutions. Working at Johnson & Johnson Vision means contributing to meaningful healthcare innovation as part of a global organisation driven by purpose and impact.
