Job Title: Staff Scientist, Microbiological Quality & Sterility Assurance (MQSA)
Description:
Support and lead microbiological quality and sterility assurance activities across a global medical device portfolio. The role focuses on contamination control, sterilization validation, microbiological quality, regulatory compliance, and support for new product introductions within a regulated environment.
Sectors:
Life Sciences – Medical Devices, Pharmaceuticals
Company Size & Type:
Global Healthcare Manufacturer
Non-Negotiable Requirements:
- Experience in the medical device or pharmaceutical industry within a GMP and/or ISO regulated environment
- Experience in microbiology and sterility assurance
- Experience with sterilization validation, including terminal sterilization, aseptic processing, and/or reprocessing
- Experience with contamination control and environmental monitoring/control practices
- Experience with sterilization methodologies such as gas, heat, and/or radiation sterilization
- Bachelor's degree in Microbiology, Biology, Engineering, or a related scientific discipline
- Experience developing, validating, or transferring microbiological or sterilization test methods
- Experience supporting audits, inspections, or compliance activities within regulated manufacturing environments
Desirable Requirements:
- Experience interacting with regulatory authorities
- Experience conducting technical assessments
- Advanced degree (MSc or PhD) in a relevant discipline
- Experience with CAPA activities
- Experience supporting new product introduction (NPI) projects
- Experience with contract sterilization sites
- Experience writing validation protocols and reports
- Experience working with Regulatory Affairs teams
- Experience leading cross-functional or international project teams
Responsibilities:
- Execute microbiological quality and sterility assurance strategies across the product portfolio
- Support new product introduction activities, including sterilization modality selection, protocol development, and regulatory collaboration
- Lead validation activities for contract sterilization sites, including process characterization and cycle development
- Manage the lifecycle of aseptic processing, microbiological, and sterilization processes
- Develop, validate, approve, and transfer microbiological and sterilization test methods
- Conduct site audits and support corrective action activities
- Support internal and external regulatory inspections and audit responses
- Collaborate with manufacturing, quality, regulatory, and external partners to maintain microbiological compliance and sterility assurance standards
Additional Information:
- Contract: 6 months (possible extension)
- Location: Groningen, Netherlands
- Hours: 40 hours per week
- On-site Requirement: Minimum 3 days per week
- Travel: Up to 50%