Quality Engineer – CSV & Digital Systems

SGS_JOB_3565

Business Support
 Florida
technical writing skills
VMP
URS
FRS
HDS

Contract - 6 months with possible extension

Location: Davie, FL 100% Onsite Recent Master’s 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).

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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