Quality Engineer - CSV & Digital Systems

SGS Consulting

Florida

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).

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Vacancy posted more than 2 months ago

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