Job Summary
Job Description (JD)
Position: Computer System Validation (CSV) Consultant / Lead
Location: US NJ
Domain: Life Sciences / Pharmaceutical Manufacturing
Experience: 10+ Years
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.
Key Responsibilities
Job Description (JD)
Position: Computer System Validation (CSV) Consultant / Lead
Location: US NJ
Domain: Life Sciences / Pharmaceutical Manufacturing
Experience: 10+ Years
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 |