Job Description


Our Client, a Pharmaceutical company, is looking for a Quality Engineer – CSV & Digital Systems for their Davie, FL location.
 

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 , CFR Part , 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 systems including:
  • MES / EBR platforms (, Werum PAS-X or similar)
  • Historians (OSIsoft PI or equivalent)
  • Advanced analytics tools (Seeq, used for GxP trending)
  • Empower and other lab systems
  • Review configurations related to data acquisition, time stamping, audit trails, access control, and electronic records/...

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