Senior CSV Lead: Life Sciences Validation & Compliance

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

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.