Validation Manager (all genders) | Fixed-term contract for 2 years | Full-time
Core
Managing validation of new manufacturing processes and product introductions for melt extrusion, secondary packaging, and autoinjector assembly in a cGMP environment.
Role type
Validation Manager
Builds
Production-ready pharmaceutical manufacturing processes and packaging solutions
Domain
Pharmaceutical manufacturing (solid dosage forms, combination products, medical devices)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, validation planning, statistical data analysis, process troubleshooting, scale-up, regulatory inspection support, deviation investigation, technical trial execution
Preferred skills
Experience with Annex 15 and EU GMP Guide, knowledge of pharmaceutical dosage form evaluation, leadership in international teams
Technologies
cGMP systems, validation software, statistical analysis tools
Responsibilities
Prepare annual validation master plans and templates, track and trend product/process data, lead investigations of quality deviations, execute technical trials, present validation concepts during regulatory inspections, support Product Quality Report preparation
Seniority
Mid-level, hands-on IC
