CSV and Validation EngineerKatalyst Healthcares and Life Sciences • Jersey City, NJ, United States
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CSV and Validation Engineer
Katalyst Healthcares and Life Sciences • Jersey City, NJ, United States
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job_description.job_card.job_description5 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, ValGenesis, Veeva, MasterControl, or TrackWise. Excellent technical writing, organization, and cross- functional communication.
Job Description :
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 :
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Validation Engineer • Jersey City, NJ, United States
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