- Shift: Monday to Friday 8am – 5 pm
- 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.
- 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.
- Assess and approve data flows, interfaces, and integrations between systems.
- Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems.
- 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.
- 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. xhuatnn
- Direct experience supporting manufacturing or utilities systems (not just lab systems).
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Computer System Validation - Fort Lauderdale - Axelon Services Corporation
Description
Submit your CV and any additional required information after you have read this description by clicking on the application button.
Job Title: Computer System Validation (CSV)
Location: 4955 Orange Drive, Davie, FL
Duration: Contract: 6 months with possible extension
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Computer System Validation
Only for registered members Davie
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Only for registered members Coral Springs
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Computer Systems Validation Consultant
Only for registered members Coral Springs, FL
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Computer Systems Validation Consultant
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Only for registered members Coral Springs, FL
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System Validation Engineer -- KUMDC5729024
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Quality Engineer
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Quality Engineer
Only for registered members Fort Lauderdale
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Quality Engineer
Only for registered members Fort Lauderdale
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Enrollment Reporting Reviewer
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Snr Mgr, Payroll Process
Only for registered members Fort Lauderdale
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IT Reporting Consultant
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Only for registered members Fort Lauderdale
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Field RF Technician
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MEP Superintendent
Only for registered members Fort Lauderdale