Validation specialist - Fill Line transition (North of France)
Validation Specialist - Fill Line Transition (North of France)
A leading bio-pharmaceutical organisation is undertaking a strategic upgrade of its aseptic operations, transitioning a legacy RABS filling line to Isolator technology at its site in northern France. We're looking for a seasoned Validation Specialist with hands-on experience in sterile manufacturing environments to support the end-to-end execution of this project.
As a validation specialist you will...
* Lead or support validation activities related to equipment, processes, and cleaning during the RABS-to-Isolator transition
* Contribute to URS development, FAT/SAT coordination, and protocol drafting
* Interface with cross-functional teams (Engineering, QA, Manufacturing) to ensure compliant execution
* Support change control and risk assessment documentation aligned with Annex 1 and GMP guidelines
* Troubleshoot challenges during installation and qualification phases
* Ensure validation deliverables meet regulatory and site-specific standards
As a validation specialist you have...
* Strong background in aseptic processing, isolator systems, and sterile facility validation
* Prior involvement in Fill/Finish tech transfer or sterile line upgrades
* Comfort working on-site and coordinating with internal and external stakeholders
* Detail-oriented, pragmatic, and proactive mindset with clear communication skills
* Fluent in French and English
Contractor-based assignment with flexible terms and potential support for travel and accommodation.
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