Computer System Validation
Axelon Services CorporationDavie, FL
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Job Description
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).
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FAQs About Computer System Validation Jobs at Axelon Services Corporation
What is the work location for this position at Axelon Services Corporation?
This job at Axelon Services Corporation is located in Davie, FL, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Axelon Services Corporation?
Employer has not shared pay details for this role.
What employment applies to this position at Axelon Services Corporation?
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