Microbiological Quality & Sterility Assurance Scientist

We are seeking an experienced Staff Scientist - Microbiological Quality & Sterility Assurance to support global sterility assurance and microbiological quality strategies within a highly regulated medical device environment.

You will join a technical leadership team responsible for ensuring safe, compliant, and effective sterilization and contamination control practices across product development and manufacturing operations.

In this role, you will work closely with cross-functional teams including R&D, Quality, Regulatory Affairs, and Manufacturing to support new product introductions, validation activities, and continuous improvement of microbiological processes.

Job Description
As a Staff Scientist, you will be responsible for leading and supporting microbiological quality and sterility assurance activities across the full product lifecycle. You will guide validation strategies, support regulatory compliance, and evaluate new technologies related to sterilization and contamination control. You will play a key role in new product introduction projects, ensuring sterility assurance requirements are defined and implemented effectively. In addition, you will support manufacturing operations by assessing risks, leading investigations, and driving improvements in aseptic processing, sterilization, and environmental control systems. A significant part of this role involves collaboration with internal stakeholders and external partners, including contract manufacturers and sterilization vendors. You will also contribute to audit readiness, regulatory submissions, and the development of global standards and best practices.

Responsibilities

• Lead sterilization and aseptic process validation activities across multiple technologies (EO, gamma, e-beam, moist and dry heat).
• Support New Product Introduction (NPI) projects, including validation strategies, protocol development, and regulatory input.
• Develop and review validation documentation such as protocols, reports, and risk assessments.
• Act as subject matter expert for microbiological quality, sterility assurance, and contamination control.
• Support the design and validation of cleanrooms, water systems, and controlled environments.
• Conduct site assessments, audits, and gap analyses, and support CAPA implementation.
• Collaborate with R&D, Quality, Manufacturing, and external partners on process improvements and troubleshooting.
• Support method development, validation, and transfer for microbiological testing (e.g., bioburden, sterility, endotoxins).
• Contribute to regulatory submissions and support inspections and audits.
• Drive continuous improvement initiatives and contribute to global standardization efforts.
• Provide training and mentorship to build microbiological and sterility assurance capabilities across teams.
• Participate in the evaluation and selection of suppliers, contract manufacturers, and sterilization vendors.

Requirements

• Master's or PhD in Microbiology, Biology, Engineering, or a related discipline.
• Extensive experience in microbiological quality and sterility assurance within a regulated industry (medical devices or pharma).
• Strong expertise in sterilization validation, including terminal sterilization and aseptic processing.
• Knowledge of multiple sterilization methods (gas, heat, radiation).
• Experience with environmental monitoring, cleanroom management, and microbiological testing.
• Familiarity with GMP, regulatory requirements, and global standards.
• Experience with audits, inspections, and CAPA processes is preferred

Benefits

• Region: Groningen area
• Hybrid working model (minimum 3 days on-site)
• Travel: approximately 50%
• Contract type: to be discussed (permanent or project-based)
• Opportunity to work in a highly innovative and regulated environment
• Exposure to global manufacturing and R&D operations
• Professional development within a technical leadership role