Summary
In this role, you will be driving both production excellence and digital transformation, this role combines hands-on Upstream GMP manufacturing with Automation SME leadership. You will partner with cross-functional teams to design and deploy MES and PCS (Delta V/Unicorn) solutions, ensuring a seamless transition from facility setup to live operations
Department :
Commercial Drug Substance (DS) Manufacturing
Responsibilities : Represent Manufacturing team as key contact person to work with Automation team on process related designs technical standards. Support new facility design and validation with focus on integration of process equipment and MES (Electronic Batch Record) into mainframe control systems (PCS, OT etc.). Involve or review design and commissioning documents (FS, FAT/SAT, IQ/OQ protocols etc.) to ensure process equipment integration requirements are in place and validated. Involve in key process equipment FATs and ensure the integration design and succe...