Duration: Approximately 6-8 weeks, but an extension is likely.
Location: Pau, France
Languages: French and English
Job Description:
Our client is seeking equipment validation contractors as their URS documents are incomplete and misrepresent clarifications and updates gathered during existing supplier discussions. These URS documents are critical inputs for our qualification phases, including Installation Qualification, Operational Qualification, and Performance Qualification.
Duties & responsibilities:
- Complete and update existing URS documents to include all relevant technical and functional requirements.
- Ensure all requirements are testable and traceable throughout the IQ, OQ, and PQ stages.
- Incorporate inputs and clarifications derived from supplier interactions and internal stakeholder feedback.
- Draft or updating URS in regulated environments (e.g., GMP)
- Write IQ, OQ, and PQ protocols
- Familiar with biotech/pharmaceutical processing equipment
- Able to engage with engineering, QA, and supplier teams
- Fluent in French and English
- Provide updates and validation of systems such as:
- Tanks and Lines
- Tangential Flow Filtration (TFF)
- Chromatography Skid
- Filter Dryer
- HVAC and Cleanroom Systems
- Water System (PWEC)
- Other relevant equipment as needed
EU: Equipment Validation (URS) (237499)
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