We are looking for Computer System Validation Lead for our client in Raritan, NJ
Job Title: Computer System Validation Lead
Job Location: Raritan, NJ
Job Type: Contract
Pay Range: $43.00hr - $48.00hr
Job Overview:
The candidate must have hands-on experience validating and implementing infrastructure systems associated with infrastructure-related applications.
Requirements:
- Experience in the pharmaceutical, biotechnology, or medical device industry.
- 2+ years of experience with System Development Lifecycle (SDLC).
- 3+ years of experience in Computer System Validation (CSV) based on the role selected, with experience in FDA and/or globally regulated environments and a good understanding of GxP standards and risk-based validation.
- Knowledge of FDA guidance and industry standards (e.g., GAMP).
- Experience writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, and Compliance/Validation Reports).
- Experience reviewing system test and user acceptance test scripts, Traceability Matrices, and Design Specs.
- Experience in QA methodologies, designing, reviewing, and approving Test Plans, systems and UAT test scripts, and Test procedures.
- Strong verbal and written communication skills with the ability to work as a team player, lead a team, or accomplish tasks without supervision.
- Ability to work with remote teams and support several changes/projects simultaneously.
- Ability to provide validation guidance, timely reviews, and escalations to management.
- Ability to support working hours from 9:00 AM to 3:00 PM US Eastern Time.
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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.
