CSV Lead
Listed on 2026-09-18
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
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: Our official website is We do not operate or authorize any other websites representing Diverse Lynx LLC. Job Title: CSV Lead
Location: New Jersey, USA (Hybrid, 3 days in Office)
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 SummaryWe 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 SkillsCore 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.
" GAMP
5.
" 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 Client-X, Syncade, etc.).
" Experience with labeling platforms (Loftware, Nice Label, Bartender).
" Experience with SAP and manufacturing integrations.
" Agile delivery experience.
" Audit and inspection support experience.
Disclaimer
: Diverse Lynx LLC is an Equal Opportunity Employer. All applicants and employees are evaluated without discrimination, based solely on their qualifications, ability, competence and performance. This email and its attachments may contain confidential or proprietary information and is intended only for the recipient(s). If you received this message in error, please disregard it and notify the sender. If you no longer wish to receive our communications, you may at any time.
Security Notice
: Our official website is We do not operate or authorize any other websites representing Diverse Lynx LLC.
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