Opportunity Description
Senior Consultant – Commission & Qualification Engineer, Life SciencesWe are looking for senior‐level consultants experienced in Commissioning & Qualification Engineering within the Life Sciences domain.Key ResponsibilitiesCommissioning & Qualification (C&Q)Develop and execute commissioning plans and IQ/OQ/PQ protocols for IT, automation, OT, and digital systems.Review vendor documentation (URS, FAT/SAT, design specifications) and integrate them into the qualification process.Perform system risk assessments, GxP impact assessments, and 21 CFR Part 11 / Annex 11 evaluations.Computerized System Validation (CSV) – IT & OT SystemsExecute CSV activities aligned with GAMP5 and company SOPs.Validate integrated systems such as LIMS, ELN, CDS, QMS/eQMS, MES, DCS, SCADA, PLC‐based systems, Building Management Systems (BMS/HVAC), and process equipment automation (CIP/SIP, reactors, isolators, autoclaves, utilities).
Create CSV deliverables: URS, FS, DS, configuration specifications, RTM, v...
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