Computer System Validation

Job Title: Computer System Validation (CSV) Location: 4955 Orange Drive, Davie, FL Duration: Contract: 6 months with possible extension Shift: Monday to Friday 8am – 5 pm Key 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. Digital Systems & Platforms: Act as Quality reviewer/approver for systems including: MES / EBR platforms (e.g., Werum Client-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/signatures. Ensure proper segregation between GxP vs non-GxP analytics use cases. Data Integrity & Compliance: Assess and approve data flows, interfaces, and integrations between systems. Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems. Cross-Functional Collaboration: Partner with Engineering, Automation, MS&T, IT, and Operations to: Enable faster project execution with compliant validation strategies Avoid over-validation while maintaining inspection readiness Provide Quality input during project design, FAT/SAT, and commissioning phases. Required Qualifications: Education: Master's degree in Engineering, Computer Science, Life Sciences, or related field. 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).