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