Quality Engineer - CSV & Digital Systems
Listed on 2026-10-18
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, Data Analyst
Job Responsibilities
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. Act as Quality reviewer/approver for MES / E platforms (e.g., Werum PAS-X or similar), Historians (OSIsoft PI), Advanced analytics tools (Seeq), 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. Assess and approve data flows, interfaces, and integrations between systems. Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems. Partner with Engineering, Automation, MS&T, IT, and Operations to enable faster project execution with compliant validation strategies, avoid over-validation, and maintain inspection readiness.
Provide Quality input during project design, FAT/SAT, and commissioning phases.
Strong working knowledge of CSV lifecycle & GAMP 5, 21 CFR Part 11 / Annex 11, Data Integrity (ALCOA+). Practical experience with MES / E systems, Process Historians (PI), 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:
Werum PAS-X, Seeq, PI Vision, Power BI, Agile/Lean validation approaches, C&Q integration with CSV. Experience with FDA inspections related to computerized systems and site digitalization or Industry 4.0 initiatives. Key competencies:
Risk-based decision making, strong documentation review and technical writing skills, ability to challenge constructively, pragmatic mindset, and comfortable working at the intersection of Quality, Engineering, and IT.
Recent Master’s graduate in Engineering, Computer Science, Life Sciences, or related field. 3–5 years experience in pharmaceutical or regulated manufacturing; minimum 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). Medical Screening Requirements:
Basic background check, 11-panel drug + Fentanyl, Vision screen (Near, Far, Color, Depth, Peripheral), Spirometry & OSHA Respirator Questionnaire.
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