Summary:
Join the owner-side team for the Basic Design of a new Fill-Finish facility (multi-product: syringes & cartridges) at our client's Bruxelles site. As Wash & Sterilization SME, you will define strategies for washers, autoclaves, and CIP/SIP systems, ensuring aseptic readiness, compliance, and efficient turnaround.
Key Responsibilities:
* Define requirements for utensil washers, autoclaves, CIP/SIP cycles and interfaces.
* Develop cleaning & sterilization strategies, cycle concepts, and load maps.
* Ensure segregation of dirty/clean flows and zoning in compliance with GMP Annex 1.
* Provide URS, PFDs/P&IDs, equipment lists, and utility load inputs.
* Collaborate with QA/Validation/HSE/Operations for sterility assurance.
Requirements:
* Strong background in aseptic processing, washers, and autoclaves.
* Experience with cycle/load development and qualification planning.
* Solid knowledge of GMP Annex 1 and utility integration.
* Fluent English; French is a plus.