Computer Science Jobs 2026 (Now Hiring) – Smart Auto Apply

Job Title: Computer System Validation (CSV)Location: 4955 Orange Drive, Davie, FLDuration: 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).