CSV Lead Consultant at Princeton, NJ (Hybrid, 3 days in Office) || W2 Only

CSV Lead Consultant

Princeton, NJ (Hybrid, 3 days in Office)

Long Term Contract

• Mandatory Skills- Computer System Validation (CSV), GxP Systems & Compliance, Manufacturing Domain Knowledge, Labeling Systems Knowledge, Validation Testing (IQ/OQ/PQ) , Validation Documentation , FDA 21 CFR Part 11 / GAMP5 , Risk Assessment & Change Control , Stakeholder Management , Audit & Inspection Support

Role Summary

• We are seeking an experienced Computer System Validation (CSV) Professional with strong expertise in regulated pharmaceutical and life sciences environments. The candidate will be responsible for validating GxP-regulated systems, supporting manufacturing and labeling applications, collaborating with business and technical stakeholders, and ensuring compliance with regulatory requirements.

Key Responsibilities

• Lead and execute Computer System Validation activities for GxP-regulated applications.
• Develop and review validation deliverables including:
• Validation Plans
• Risk Assessments
• User Requirement Specifications (URS)
• Functional Specifications
• IQ/OQ/PQ Protocols
• Traceability Matrices
• Validation Summary Reports
• Support validation of manufacturing and labeling systems.
• Perform impact assessments, change control assessments, and periodic reviews.
• Collaborate with Quality, Manufacturing, Regulatory, Business, and IT teams.
• Ensure compliance with FDA, GAMP5, 21 CFR Part 11, Annex 11, and applicable regulatory requirements.
• Coordinate testing activities and review test evidence.
• Support audits, inspections, and compliance initiatives.
• Provide validation guidance throughout system implementation and enhancement projects.

Required Skills

Core CSV

• Strong Computer System Validation experience.
• Hands-on experience in regulated pharmaceutical or life sciences environments.
• Experience with validation lifecycle documentation.

Manufacturing & Labeling

• Strong understanding of manufacturing execution and shop-floor processes.
• Knowledge of labeling systems and related validation requirements.
• Experience supporting manufacturing applications.

Testing & Validation

• Expertise in IQ/OQ/PQ execution.
• Risk-based validation approach.
• Traceability management.
• Defect management and test coordination.

Regulatory & Compliance

• GxP compliance.
• FDA 21 CFR Part 11.
• GAMP5.
• Data Integrity principles (ALCOA+).
• Change Control and CAPA processes.

Stakeholder Management

• Ability to engage business users and technical teams.
• Excellent communication and documentation skills.
• Experience working in global delivery models.

Preferred Skills

• Experience with MES systems (Werum PAS-X, Syncade, etc.).
• Experience with labeling platforms (Loftware, NiceLabel, Bartender).
• Experience with SAP and manufacturing integrations.
• Agile delivery experience.
• Audit and inspection support experience.

Skill Requirements

Skill	Mandatory (Y/N)	Proficiency Level (1-5)
Computer System Validation (CSV)	Y	5
GxP Systems & Compliance	Y	5
Manufacturing Domain Knowledge	Y	5
Labeling Systems Knowledge	Y	4
Validation Testing (IQ/OQ/PQ)	Y	5
Validation Documentation	Y	5
FDA 21 CFR Part 11 / GAMP5	Y	4
Risk Assessment & Change Control	Y	4
Stakeholder Management	Y	5
Audit & Inspection Support	N	3