Katalyst Healthcares and Life Sciences
CSV and Validation Engineer
Katalyst Healthcares and Life Sciences, Jersey City, New Jersey, United States, 07390
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:
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, ValGenesis, Veeva, MasterControl, or TrackWise. Excellent technical writing, organization, and cross- functional communication.
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, ValGenesis, Veeva, MasterControl, or TrackWise. Excellent technical writing, organization, and cross- functional communication.