Sterility Assurance (QC) Specialist

Our client operates within the Biopharma domain in the Netherlands. The site is operating within a GMP pharmaceutical manufacturing environment and is seeking additional Sterility Assurance / QC Microbiology support to strengthen contamination control, Annex 1 compliance, and shop-floor execution.

You will be responsible for hands-on sterility assurance and contamination control activities on-site, directly supporting manufacturing, QC, and QA teams. This role is strongly field-oriented and technical, requiring someone who can personally draft, own, and execute risk assessments and technical documentation, and who is comfortable operating autonomously in Grade A/B environments.

Essential Requirements

• Education Requirement: MSc in Microbiology (mandatory).
• Experience: Minimum 2 years hands-on experience in QC Microbiology (current or previous role).

• +2 additional years in a Sterility Assurance role within a pharmaceutical manufacturing environment.

• Strong shop-floor presence with practical, not supervisory-only, exposure.

• In-depth, practical knowledge of EU GMP Annex 1 (2022) (non-negotiable).

• Working knowledge of PDA guidance documents is highly preferred.
• Contamination Control & Risk Management: The candidate must have personally written, owned, and defended contamination control documentation, including hands-on experience with risk assessments related to:

  • Environmental Monitoring strategies

  • Material and personnel flows

  • PUPSIT design and rationale

  • Gowning concepts for aseptic areas

  • Microbiological controls for incoming raw materials as part of a robust CCS

  • Definition of CCIT strategies

• Sterilization & Sanitization

  • Solid experience with steam sterilization processes, including SIP and autoclaves

  • Ability to define sanitization strategies for areas and equipment in line with Annex 1

  • Application of appropriate risk-based mitigation measures

• Deviation & Excursion Management

  • Acted as the primary driver for Grade A/B environmental monitoring excursions

• Demonstrated autonomy in defining:

  • Immediate containment actions

  • Root cause investigations

  • Short- and long-term CAPAs

• Aseptic Operations & Training

  • Personally delivered training on aseptic practices, including gowning, behaviour, and movements in classified areas

  • Participation in multiple APS / media fills (legacy media fill experience included)
  • ???????Sufficient exposure to provide microbiological oversight and critically assess process vulnerabilities from a sterility assurance perspective

???????Note: This is not a managerial role. While people-management experience is welcomed, the core requirement is hands-on technical execution and ownership rather than delegation.

Practicalities

Start Date: ASAP
Contract Duration: 6 months (extension possible)
Location: Netherlands
Process: Fast-moving process with a single Teams interview with senior site stakeholders, followed by a rapid decision.

Interested?

Interviews and offers can move quickly.
Send your CV to c.girdwood@panda-int.com to secure your place in the process.