Location: Greater region, Belgium
Contract: Long-term contract – 12 months (extension possible)
Languages: English & Dutch (mandatory)
Position Overview
We are seeking an experienced QA Cleaning & Sterilisation Validation Expert with a strong background in aseptic pharmaceutical manufacturing.
This role focuses on cleaning validation, sterilisation validation, autoclave cycle development, and QA oversight within GMP-regulated aseptic environments. The successful candidate will play a key role in ensuring sterility assurance, regulatory compliance, and validation excellence across manufacturing operations.
Key Responsibilities
Lead and review cleaning validation strategies for equipment, utilities, and aseptic manufacturing processes
Develop, execute, and approve sterilisation validation protocols and reports (moist heat, autoclaves, SIP systems)
Design, optimize, and challenge sterilisation cycle profiles and load configurations
Support autoclave qualification (IQ/OQ/PQ) and periodic requalification
Perform risk assessments (FMEA, contamination control strategies)
Ensure compliance with EU GMP, FDA, and ICH guidelines
Review and approve validation documentation within the QA framework
Support deviation investigations, CAPAs, and change controls
Participate in regulatory inspections and audit readiness activities
Collaborate cross-functionally with Manufacturing, Engineering, MSAT, and QC teams
Required Experience & Qualifications
Minimum 5 years of experience in aseptic pharmaceutical manufacturing
Strong expertise in:
Cleaning validation (CIP/COP systems preferred)
Sterilisation validation (moist heat, autoclaves, depyrogenation)
Aseptic process validation
Autoclave cycle development and thermal mapping
In-depth understanding of:
EU GMP Annex 1
Sterility assurance principles
Contamination control strategies
Experience providing QA oversight of validation activities
Hands-on experience in sterile or aseptic environments is essential
Fluent in English and Dutch (spoken and written) – mandatory
Preferred Profile
Experience in sterile injectables, biologics, or advanced therapy products
Familiarity with Grade A/B cleanroom environments
Strong technical writing and documentation skills
Independent, detail-oriented, and compliance-driven
Inspection-ready mindset with strong problem-solving capabilities
Contract Details
12-month long-term contract
On-site presence required within the greater region
Competitive daily rate depending on experience
Immediate start preferred