Key Skills

Job Description

Intralogistics Automation Validation Expert — Freelance Major Pharmaceutical Manufacturer | Freelance / Day Rate | Immediate Start | Europe A major pharmaceutical manufacturer is running parallel automated warehouse programmes across multiple sites. The live track has a problem. The supplier has submitted SAT protocols. The gaps are already identified — test depth is insufficient, stress testing is inadequate, the case list does not cover real operational scenarios. Go-live is six to eight weeks out. Sign-off as-is carries real post-go-live risk on a platform that scales ten to twenty times into a flagship programme landing in 2027. The Role Owner-side expert embedded directly alongside senior project leadership. Not a coordination role. This requires someone who can personally judge whether a test case list and ITOT protocol are adequate — and act on that judgement. The scope runs across the full validation package. Where the supplier's protocols fall short, this person leads the conversation about remediation, including who absorbs the cost. What You Will Do Review and challenge existing SAT protocols — test depth, stress testing, case coverage Design and oversee risk-based test cases that reflect real operational scenarios Validate IT/OT integration: PLC to WCS, WCS to WMS, WMS to MES/ERP data handoffs Ensure GMP data integrity and audit trail compliance throughout Lead supplier-side negotiations on gap remediation and cost ownership Build the lessons-learned framework that scales into the 2027 flagship programme Ideal Profile Intralogistics automation validation within a GMP-regulated environment — first choice CQV Manager whose background is automation and controls, not facility or utility qualification — credible fallback Senior Automation or Controls Validation Engineer with material handling or robotics exposure in life sciences Systems Integration Test Lead from an adjacent regulated industry, paired with a CQV or QA partner for GMP language Note: Facility and utility CQV backgrounds — HVAC, cleanroom, purified water, steam — do not transfer to this scope. Technical Background AS/RS | Conveyor systems | Robotic material handling | WCS / WMS | PLC / SCADA | MES / ERP integration | FAT / SAT | IQ / OQ | GMP data integrity | 21 CFR Part 11 Commercial Dimension This role sits at the supplier negotiation table. The ability to hold a position on cost ownership and testing adequacy with a major automation supplier is as important as the technical input. Engagement Details Freelance / contract — competitive day rate commensurate with seniority Immediate start — go-live window is six to eight week Send your CV and day rate expectation via message. We are speaking with candidates at an earliest convenience this week.

Core Responsibilities

The role involves reviewing and challenging existing SAT protocols while overseeing risk-based test cases for automated warehouse systems. You will also lead supplier-side negotiations regarding gap remediation and ensure GMP data integrity throughout the project lifecycle.

Requirements

Candidates must have extensive experience in intralogistics automation validation within a GMP-regulated environment. A strong technical background in automation, controls, and systems integration is essential for this senior-level position.