CSV Lead
katalysthealthcaresPiscataway (NJ)
About the role
Roles & Responsibilities:
Lead and manage Computer System Validation (CSV) activities across regulated Life Sciences projects.
Develop and review validation plans, protocols, test scripts, reports, and validation documentation.
Lead validation lifecycle activities including URS, FS/DS, IQ, OQ, PQ, UAT, and RTM.Perform risk assessments and ensure systems are validated in compliance with GxP requirements.
Support validation of GxP computerized systems, laboratory systems, manufacturing systems, and enterprise applications.
Manage deviations, CAPA, change controls, and validation-related investigations.
Provide technical leadership and coordinate with QA, IT, Engineering, Manufacturing, and Business teams.
Ensure compliance with FDA regulations, 21 CFR Part 11, GAMP5, and data integrity requirements.
Support audits, inspections, and inspection-readiness activities.
Manage project timelines, deliverables, and validation documentation.
Required Qualifications:
- 10+ years of experience in CSV / Computer System Validation within Pharma, Biotech, Medical Device, or Life Sciences.
- Strong knowledge of GxP validation lifecycle and risk-based validation approaches.
- Hands-on experience with URS, FS/DS, IQ/OQ/PQ, UAT, RTM, and validation reports.
- Strong knowledge of 21 CFR Part 11, GAMP5, FDA, and data integrity requirements.
- Experience with deviations, CAPA, change control, and risk assessments.
- Strong technical documentation and project leadership skills.
- Experience working with cross-functional teams in regulated environments
- Experience with laboratory systems such as LIMS, CDS, ELN, or SDMS.Experience with manufacturing systems, MES, ERP, or automation-related systems.
- Experience with systems such as LabWare, Empower, TrackWise, Veeva, or SAP.Experience with data integrity assessments and audit/inspection support.
- Experience leading CSV teams and managing multiple validation projects.
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