CSV Lead

Katalyst CRO; Piscataway Township (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in New Jersey is seeking a senior CSV lead to steer Computer System Validation across regulated Life Sciences projects. You will develop validation plans, protocols, and reports, and coordinate across QA, IT, Engineering, Manufacturing, and Business teams.

The role emphasizes risk-based validation, compliance with FDA 21 CFR Part 11 and GxP, and readiness for audits and inspections. The ideal candidate has 10+ years of CSV experience and proven leadership of cross-functional

Qualifications

• 10+ years of CSV/Computer System Validation within Pharma, Biotech, Medical Device, or Life Sciences.
• Strong knowledge of GxP validation lifecycle and risk-based approaches.
• Hands-on with URS, FS/DS, IQ/OQ/PQ, UAT, RTM, and validation reports.
• Proficient with 21 CFR Part 11, FDA, and data integrity requirements.
• Experience with deviations, CAPA, change control, and risk assessments.
• Strong technical documentation and project leadership skills.
• Experience with cross-functional teams in regulated environments.
• Experience with laboratory systems (LIMS, CDS, ELN, SDMS) and MES/ERP systems.
• Experience with LabWare, Empower, TrackWise, Veeva, or SAP.
• Experience leading CSV teams and managing multiple validation projects.

Responsibilities

• Lead and manage 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.

Skills

CSV leadership

Validation planning

Risk assessment

Cross-functional leadership

Documentation skills

QA coordination

Deviations & CAPA

Regulatory compliance

Tools

LIMS

EDMS/ELN

SDMS

LabWare

Empower

TrackWise

Veeva

SAP

Job description

• 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.

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.