PAS-X Specialist - Data Modelling Validation

A leading biopharmaceutical manufacturing site in Toulouse is seeking an experienced PAS‑X Validation Specialist to support ongoing MES/EBR deployment and data‑modelling activities. The specialist will work within the digital manufacturing and QA/CSV teams to ensure compliant design, configuration, and validation of PAS‑X workflows, MBRs, and system integrations in a GMP environment.

Key Responsibilities

• Lead validation activities for PAS‑X across MBR/EBR design, configuration, and execution modules.
• Translate process descriptions and manufacturing workflows into PAS‑X data models, including parameters, phases, operations, materials, and equipment structures.
• Develop and maintain validation deliverables: URS, FS/DS reviews, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation reports.
• Execute and document test activities for PAS‑X functionality, integrations, and recipe execution scenarios.
• Support MBR/EBR design reviews, ensuring alignment with GMP, data integrity, and site manufacturing standards.
• Collaborate with Manufacturing, QA, Automation, and IT to troubleshoot issues and ensure validated state of the MES platform.
• Contribute to change control, deviation management, and periodic review of validated systems.
• Ensure compliance with EU GMP, Annex 11, GAMP 5, and site CSV/CSA methodologies.

Required Experience

• Strong hands‑on experience with PAS‑X (MBR/EBR design, modelling, configuration, or validation).
• Proven track record delivering CSV/CSA activities in GMP pharmaceutical or biotech manufacturing.
• Solid understanding of MES data structures, recipe modelling, and batch execution workflows.
• Experience validating integrations between PAS‑X and systems such as SAP, LIMS, historians, automation layers.
• Familiarity with GAMP 5, Annex 11, 21 CFR Part 11, and data integrity principles.
• Ability to interpret process maps, P&IDs, and manufacturing documentation to build accurate MES logic.
• Strong documentation, testing, and cross‑functional communication skills.
• English required; French beneficial for on‑site collaboration.

Contract Details

• Location: Toulouse, France (some on‑site presence required)
• Duration: 6 months (extension possible based on project phase)
• Start: ASAP
• Engagement: Freelance/contractor via local entity or umbrella
• Team: MSAT