Validation Consultant

Job Title: CSV Consultant - 10+ Years of Exp is Mandatory to have

Location: Raritan, NJ (Hybrid – 3 Days Onsite)

Employment Type: W2 Contract

Note: Currently not accepting transferring Visa's or Sponsorships & C2C, C2H, or 1099 engagements.

Role Overview

We are seeking an experienced CSV Consultant to support Business Separation activities for large global and regional GxP computerized systems within a regulated pharmaceutical environment.

Required Qualifications & Experience

• 10+ years of relevant Computer System Validation (CSV) experience.
• Experience supporting Acquisitions, Separations, and Divestiture projects.
• Strong experience with SAP and ERP systems.
• Ability to manage end-to-end validation activities, including inventory, assessments, remediation, and final disposition.
• Experience with Infrastructure Qualification (IQ) and Business System Validation.
• Background in the pharmaceutical, biotechnology, or medical device industry.
• Experience working in FDA and/or globally regulated GxP environments.
• Strong understanding of GxP standards and Risk-Based Validation methodologies.
• Ability to define, implement, and execute risk-based validation activities.

Key Responsibilities

• Support business separation initiatives for GxP computerized systems.
• Prepare, review, and execute validation documentation, including:
• Requirements Specifications
• Compliance/Validation Plans
• Test Protocols
• Test Summary Reports
• Compliance/Validation Reports
• SOPs and Work Instructions (WIs)
• Review System Testing, User Acceptance Testing (UAT) scripts, Traceability Matrices, and Design Specifications.
• Design, review, and approve Test Plans, System Test Scripts, UAT Scripts, and Test Procedures.
• Provide CSV and validation guidance to project teams.
• Conduct timely reviews and escalate issues to TQ Management when necessary.
• Support multiple projects and change initiatives simultaneously.
• Collaborate effectively with remote and cross-functional teams.
• Lead and mentor junior and senior validation resources as needed.

Required Skills

• Strong verbal and written communication skills.
• Ability to work independently and as part of a team.
• Leadership and mentoring capabilities.
• Excellent organizational and stakeholder management skills.