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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.