Quality Engineer - CSV & Digital Systems
SGS Consulting
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.
Skills:
- Werum PAS-X, Seeq, PI Vision, Power BI (for regulated trending)
- Agile or lean validation approaches
- Commissioning & Qualification (C&Q) integration with CSV
- Prior involvement in:
- FDA inspections related to computerized systems
- Site digitalization or Industry 4.0 initiatives
Education/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).
Vacancy posted more than 2 months ago
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