PI Historian Validation Consultant

I’m currently looking for a senior Computer System Validation (CSV) professional to join a high-impact pharmaceutical project focused on validating a PI Historian system .

On-site presence required during critical phases (SAT/IOQ, PQ)

Up to 2 days/week remote possible

What’s the mission?

You’ll be responsible for ensuring the validation of an industrial PI Historian system (data collection, historization, archiving & usage of production data) in full compliance with GxP regulations and Data Integrity standards (ALCOA+) .

This is a hands‑on, field‑involved role — not just documentation review.

• ✔ Define and drive the validation strategy
• ✔ Lead impact assessments within change control
• ✔ Author and review URS, FRA, IQ/OQ/PQ protocols & reports
• ✔ Execute and supervise IQ/OQ/PQ testing
• ✔ Participate in Data Integrity Risk Assessments
• ✔ Coordinate with IT, Automation, Quality & suppliers

• 5+ years of CSV experience in pharma/biotech
• Strong knowledge of automated systems (PLC, SCADA, Historian, MES)
• Experience validating historian systems
• Familiarity with GAMP 5
• Professional English & French
• Someone proactive, structured, and confident enough to challenge technical solutions

This is a great opportunity for a senior validation engineer who enjoys working at the intersection of automation, IT, and quality in a regulated environment .

If you’re interested — or know someone who might be — feel free to comment or send me a direct message.