Lead CSV / Computer System Validation Engineer

Virtue America; New Jersey; On-site; USD 120,000 - 160,000; Full time

Job summary

Virtue America is seeking an experienced Lead CSV professional in New Jersey to guide validation efforts across pharma, medical device, and life sciences sectors. The role acts as the primary liaison between the CSV team and management, coordinating with OT, IT, QA, and engineering to ensure robust, compliant validation programs.

The candidate should bring 9+ years of CSV/validation expertise, strong knowledge of 21 CFR Part 11 and GAMP 5, and demonstrated leadership in delivering end-to-end

Qualifications

• 9+ years in Computer System Validation or CSV within Pharma, Medical Device, or Life Sciences.
• Strong experience with GxP compliance, SDLC, and validated systems.
• Experience validating enterprise and laboratory systems.
• Hands-on with SAP, LIMS, MES, TrackWise, and ServiceNow.
• Experience with software and lab instrument integration.
• Knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 is a plus.
• Ability to lead end-to-end validation activities independently.
• Strong communication and stakeholder management skills.
• Provide technical guidance and leadership to CSV teams.

Responsibilities

• Lead end-to-end CSV activities and ensure compliant validation.
• Act as conduit between CSV team and CSV management.
• Collaborate with cross-functional teams (OT, IT, QA, Engineering).
• Develop validation plans, protocols, and final reports.

Skills

CSV leadership

GxP compliance

IQ/OQ/PQ

Validation writing

Cross-functional

Tools

SAP

LIMS

TrackWise

ServiceNow

Job description

HIRING: Lead CSV / Computer System Validation Engineer

Employment Type: W2 ONLY

Local NJ Candidates ONLY

We are looking for an experienced Lead CSV professional with a strong background in the pharmaceutical, medical device, or life sciences industry.

This role is ideal for a senior and mature CSV professional who can serve as the key conduit between the CSV team and CSV management and work effectively with cross-functional teams.

Key Requirements

• 9+ years of experience in Computer System Validation or CSV within Pharma, Medical Device, or Life Sciences
• Strong experience with GxP compliance, SDLC, and computerized system validation
• Experience validating enterprise and laboratory systems
• Hands-on experience with systems such as SAP, LIMS, MES, TrackWise, and ServiceNow
• Experience with software and laboratory instrument integration
• Understanding of Configuration Specifications is a plus
• Strong experience with VMP, IQ/OQ/PQ, validation protocols, and validation reports
• Experience with risk assessments, CAPA, deviations, and audit readiness
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5
• Understanding of GMP and Non-GMP infrastructure and network layers
• Experience working with OT, Engineering, Qualification, IT, Quality, and other cross-functional teams
• Strong technical documentation and validation writing skills
• Ability to lead end-to-end validation activities independently
• Strong communication and stakeholder management skills
• Ability to provide technical guidance and leadership to CSV teams

We are specifically looking for a mature Lead-level CSV professional who can take ownership of validation activities and effectively communicate between the CSV team and management.