KH
CSV Lead
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Staff / Principal
1 week ago
- GxP
- CAPA
- ERP
- Veeva
- SAP
1 week ago
- 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.
- 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.
CSV Lead · Katalyst Healthcares & Life Sciences