More jobs:
Computer system validation - CSV/ CSA Engineer
Job in
Chicago, Cook County, Illinois, 60290, USA
Listed on 2026-08-12
Listing for:
Pharmatek Consulting Inc.
Full Time
position Listed on 2026-08-12
Job specializations:
-
Quality Assurance - QA/QC
IT QA Tester / Automation
Job Description & How to Apply Below
- Execute CSA and validation activities in accordance with SDLC procedures and quality expectations
- Assist in preparation of validation plans, functional risk assessments, and traceability matrices
- Support review of validation/testing documentation and change control artifacts
- Contribute to validation summary reporting and lifecycle compliance deliverables
- Provide support for CMDB management and validation tool usage as needed
- Collaborate with Digital Quality, System Owners, and Business stakeholders throughout execution
- 4–5+ years in CSV/CSA or regulated system validation support
- Working knowledge of validation lifecycle documentation and SDLC processes
- Experience reviewing test artifacts, requirements traceability, and change controls
- Ability to operate effectively in a remote, globally distributed team
- Preferred exposure to SAP or enterprise platform validation
- Preferred familiarity with GxP documentation practices and ALCOA+ principles
- Preferred experience supporting validation execution within life sciences
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