Staff Scientist Microbiological Quality & Sterility Assurance

Staff Scientist - Microbiological Quality & Sterility Assurance (MQSA)

Start: ASAP
Duration: 1 year contract (initial)
Location: Groningen
Hours: Full time (40 hrs/week)
Sector: Medical Devices | Life Sciences | Microbiology & Sterility Assurance

About the Role

A leading global medical technology organisation is seeking a Staff Scientist within Microbiological Quality & Sterility Assurance (MQSA).

In this role, you will take ownership of global microbiological quality strategies and sterility assurance across manufacturing and R&D operations. You will act as a technical authority, ensuring that all products, processes, and systems meet the highest standards of sterility, compliance, and patient safety.

You will operate at the intersection of R&D, manufacturing, and regulatory affairs, working closely with global stakeholders to implement and maintain robust microbiological quality systems. This is a highly visible position with both strategic impact and hands-on technical responsibility.

Key Responsibilities

• Lead microbiological quality and sterility assurance strategies globally
• Drive sterilization validation and aseptic processing activities
• Support NPI, validations, and product transfers
• Ensure GMP/ISO compliance and inspection readiness
• Lead investigations, deviations, and CAPA related to sterility issues
• Oversee environmental monitoring, cleanrooms, and contamination control
• Collaborate with R&D, Quality, and Manufacturing stakeholders
• Represent the organization in external industry forums

Profile

• Bachelor's degree in Microbiology, Biology, Engineering, or a related field
• Minimum 8 years of experience in medical devices or pharmaceutical industry within a GMP/ISO environment
• Strong expertise in:
• Microbiology and sterility assurance
• Sterilization validation (multiple methods)
• Aseptic processing and environmental control
• Proven experience with investigations, troubleshooting, and CAPA processes
• Experience working in complex, international and cross-functional environments
• Familiarity with regulatory requirements and interactions is preferred

Skills & Competencies

• Strong technical and scientific expertise
• Excellent stakeholder management and communication skills
• Ability to lead, influence, and mentor within a global organisation
• Structured, analytical, and solution-oriented approach
• Strong organisational and time management skills
• High attention to detail and quality mindset

Interested?

If you are looking for a technically challenging and globally impactful role within microbiological quality and sterility assurance, we encourage you to apply or get in touch for more information.

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