What are the responsibilities and job description for the CSV Lead position at Cynet Systems?
We are looking for CSV Lead for our client in Jersey City, NJ
Job Title: CSV Lead
Job Location: Jersey City, NJ
Job Type: Contract
Job Overview:
Pay Range: $50.00hr - $55.00hr
Requirement/Must Have:
- Strong Computer System Validation experience.
- Hands-on experience in regulated pharmaceutical or life sciences environments.
- Experience with validation lifecycle documentation.
- Strong understanding of manufacturing execution and shop-floor processes.
- Knowledge of labeling systems and related validation requirements.
- Experience supporting manufacturing applications.
- Expertise in IQ/OQ/PQ execution.
- Experience with risk-based validation approach.
- Experience with traceability management.
- Experience with defect management and test coordination.
- Knowledge of GxP compliance.
- Knowledge of FDA 21 CFR Part 11.
- Knowledge of GAMP5.
- Knowledge of Data Integrity principles (ALCOA ).
- Experience with Change Control and CAPA processes.
- Strong verbal and written communication skills.
- Ability to communicate effectively with stakeholders.
- Experience working in global delivery models.
Responsibilities:
- Lead and execute Computer System Validation activities for GxP-regulated applications.
- Develop and review validation deliverables including Validation Plans, Risk Assessments, and User Requirement Specifications (URS).
- Develop and review Functional Specifications, IQ/OQ/PQ Protocols, Traceability Matrices, and 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.
Nice to Have:
- 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.
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.
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Benefits
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.
Salary : $50 - $55