Quality System Validation Engineer --MEHDC5741774

Responsibilities Review and approve validation lifecycle documents including VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, and Summary Reports Ensure compliance with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ Data Integrity principles Assess change controls and evaluate GxP impact Act as Quality reviewer/approver for: MES / EBR systems (e.g., Werum PAS-X or similar) Process Historians (OSIsoft PI or equivalent) Advanced analytics tools (Seeq – GxP context) Ensure proper segregation of GxP and non-GxP analytics Support FDA and regulatory inspections Partner with Engineering, Automation, IT, MS&T, and Operations Provide Quality input during FAT/SAT and commissioning phases Required Qualifications Master’s degree in Engineering, Computer Science, Life Sciences, or related field 3–5 years in pharmaceutical or regulated manufacturing Minimum 2 years within a Quality organization 3+ years hands‑on Computer System Validation experience Direct support of manufacturing or utilities systems Required Technical Skills CSV lifecycle & GAMP 5 21 CFR Part 11 / Annex 11 Data Integrity (ALCOA+) MES / EBR systems Process Historians (PI or similar) Seeq or advanced analytics in GxP Change Control, Deviations, CAPA Risk‑based validation approach Preferred Experience PI Vision Power BI (regulated trending) FDA inspection support Industry 4.0 / Digital transformation initiatives #J-18808-Ljbffr Compunnel Inc.