About the job
Job Description
As a member of the Manufacturing Science and Technology (MSAT) team, you will oversee Validation activities (Process/Cleaning/Transport) and Performance Qualification of equipment involved in the production and purification of Monoclonal Antibodies (Mab) from cell culture (USP) and downstream processing (DSP).
Your responsibilities will include:
- Drafting master documents such as the Validation Master Plan, risk analyses, and Validation/Qualification protocols/reports, ensuring alignment with validation plans and project timelines.
- Establishing the Process Control Strategy (PCS).
- Coordinating cross-functional activities (Production/CQ/AQ/Regulatory) to support Validation and Performance Qualification studies.
- Being a key contact during client meetings for all Validation-related activities.
- Communicating project progress and associated risks to management and project teams.
- Presenting studies to production/CQ teams; ensuring the implementation and monitoring of Validation and Qualification activities on the ground.
- Analyzing and interpreting results from Validation and Performance Qualification activities.
- Proactively conducting investigations following deviations related to Validation and Performance Qualification activities.
- Implementing changes and continuous improvement activities (Change Control, CAPA).
- Participating in defining and implementing new equipment involved in processes.
- Engaging with health authorities and during internal/client audits regarding Validation and Performance Qualification activities.
This position is a day shift role based in Martillac (33) and is available for immediate hire on a permanent contract.

