Quality Engineer - CSV & Digital Systems

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 / EBR 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.

Skills:

• Strong working knowledge of CSV lifecycle & GAMP 5, 21 CFR Part 11 / Annex 11, Data Integrity (ALCOA+).
• Practical experience with MES / EBR 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.

Education/Experience:

• 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.