Quality Engineer

Title : Quality Engineer Shift Details : 8 AM - 5 PM Duration : 6 months with possible extension Core Essential skill sets (must have) : Recent Masters graduate Master's degree in Engineering, Computer Science, Life Sciences, or related field. Min 3 years experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization Min 3 years hands-on CSV experience reviewing and approving validation documentation. Direct experience supporting manufacturing or utilities systems (not just lab systems). Medical screening requirements : Key Responsibilities : Computer System Validation (CSV) Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ / OQ / PQ, RTM, Summary Reports). Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, and Data Integrity (ALCOA+) principles. Evaluate system changes through change control, assessing GxP impact and validation requirements. Support periodic reviews and re-validation activities for existing systems. Digital Systems & Platforms Act as Quality reviewer / approver for systems including : o MES / EBR platforms (e.g., Werum Client-X or similar) o Historians (OSIsoft PI or equivalent) o Advanced analytics tools (Seeq, used for GxP trending) o Empower and other lab systems Review configurations related to data acquisition, time stamping, audit trails, access control, and electronic records / signatures. Ensure proper segregation between GxP vs non-GxP analytics use cases. Data Integrity & Compliance : Assess and approve data flows, interfaces, and integrations between systems. Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems. Cross-Functional Collaboration Partner with Engineering, Automation, MS&T, IT, and Operations to : o Enable faster project execution with compliant validation strategies o Avoid over-validation while maintaining inspection readiness Provide Quality input during project design, FAT / SAT, and commissioning phases. Required Qualifications : Education : Master's degree in Engineering, Computer Science, Life Sciences, or related field. Experience : 3-5 years experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization 3+ years hands-on CSV experience reviewing and approving validation documentation. Direct experience supporting manufacturing or utilities systems (not just lab systems). Required Technical Skills : Strong working knowledge of : o CSV lifecycle & GAMP 5 o 21 CFR Part 11 / Annex 11 o Data Integrity (ALCOA+) Practical experience with : o MES / EBR systems o Process Historians (PI, etc.) o Advanced analytics platforms (Seeq) in a GxP context Ability to evaluate risk-based validation for dashboards, reports, and models. Familiarity with change control, deviations, and CAPA systems. Preferred / Nice-to-Have Experience with : o Werum Client-X, Seeq, PI Vision, Power BI (for regulated trending) o Agile or lean validation approaches o Commissioning & Qualification (C&Q) integration with CSV Prior involvement in : o FDA inspections related to computerized systems o Site digitalization or Industry 4.0 initiatives Key Competencies Risk-based decision making with quality and compliance focus Strong documentation review and technical writing skills Ability to challenge constructively while remaining solution-oriented Comfortable working at the intersection of Quality, Engineering, and IT Pragmatic mindset : compliant and business-enabling