CSV Lead

Fives DyAG Corp.; Piscataway Township (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Fives DyAG Corp. is seeking an experienced CSV Lead to manage validation activities for regulated Life Sciences projects in New Jersey. You will develop and review validation plans, protocols, and reports while guiding URS, FS/DS, IQ, OQ, PQ, and UAT processes.

Ideal candidates bring 10+ years in CSV within pharma/biotech, deep knowledge of GxP and data integrity, and strong collaboration with QA, IT, and manufacturing teams. You will ensure FDA compliance and support audits and inspections.

Qualifications

• 10+ years in CSV / Computer System Validation within Pharma, Biotech, Medical Device, or Life Sciences.
• Strong knowledge of GxP validation lifecycle and risk-based validation.
• Hands-on experience with URS, FS/DS, IQ/OQ/PQ, UAT, RTM, and validation reports.
• Knowledge of 21 CFR Part 11, GAMP5, FDA data integrity requirements.
• Experience with deviations, CAPA, change control, and risk assessments.

Responsibilities

• Lead and manage CSV activities across regulated Life Sciences projects.
• Develop and review validation plans, protocols, tests, and reports.
• Oversee validation lifecycle: URS, IQ/OQ/PQ, UAT, RTM.
• Coordinate with QA, IT, Engineering, Manufacturing, and Business teams.
• Ensure compliance with FDA regulations and data integrity requirements.
• Support audits, inspections, and inspection-readiness activities.

Skills

CSV Leadership

GxP Validation

Risk-based Validation

Documentation

Cross-functional Collaboration

Tools

LIMS

CDS

ELN

TrackWise

Veeva

SAP

LabWare

empowering systems

Job description

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.