CSV and Validation Engineer
Job in
Jersey City, Hudson County, New Jersey, 07097, USA
Listed on 2026-09-01
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-09-01
Job specializations:
-
Quality Assurance - QA/QC
-
IT/Tech
Job Description & How to Apply Below
CSV And Validation Engineer
We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs.
Responsibilities:
- Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
- Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
- Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
- Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
- Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
- Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
- Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.
Requirements:
- 5 to 10+ years in CSV/validation within regulated labs or life sciences.
- Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
- Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
- Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
- Proficiency with test and quality tools such as Client ALM/Jira/Xray, Val Genesis, Veeva, Master Control, or Track Wise.
- Excellent technical writing, organization, and cross- functional communication.
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