GxP Sr. Systems Engineer

Role: Senior Manager supporting laboratory systems delivery and validation within a biopharmaceutical GMP setting, focusing on Chromeleon CDS system upgrades and deployment. Responsibilities: administer, configure, and maintain Chromeleon CDS; support validation activities in line with GxP and data integrity standards; assist with server upgrades, change control, SOP updates, and system verification; collaborate with Digital, QC, Infrastructure, and Validation teams; ensure inspection readiness and support audit activities; identify workflow optimizations. Qualifications: 10+ years supporting laboratory informatics systems (SDMS, LIMS, CDS) in regulated biopharma environments; strong knowledge of GxP validation (GAMP 5, 21 CFR Part 11, Annex 11), system upgrades, and data integrity; experience with laboratory instrument integration; preferred experience with cloud/hybrid systems. HighValue: biopharma GMP environment, laboratory informatics validation, Chromeleon system upgrades, GxP compliance, cross-functional collaboration. WorkSetup: on-site with potential regional travel.