We are looking for Senior Computer System Validation Analyst for our client in Rahway, NJ
Job Title: Senior Computer System Validation Analyst
Job Location: Rahway, NJ
Job Type: Contract
Pay Range: $45.00hr - $50.00hr
Job Overview:
Our client is seeking a Computer System Validation Analyst to lead CSV compliance activities for capital and strategic projects within a regulated pharmaceutical environment.
Responsibilities:
- Lead Computer System Validation (CSV) compliance activities for capital and strategic projects.
- Develop, review, and approve validation lifecycle deliverables in accordance with applicable standard operating procedures (SOPs) and regulatory requirements, such as 21 CFR Part 11.
- Provide compliance guidance to project teams on Software Development Life Cycle (SDLC), Computer Software Assurance (CSA), qualification, and validation approaches.
- Participate in project meetings and CSV compliance reviews.
- Assist with project change controls and CSV compliance-related risk assessments.
- Maintain project CSV compliance trackers, metrics, and reporting.
- Approve SDLC documents as the technical unit.
Requirements:
- Minimum 5 years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), automation compliance, shopfloor, enterprise, laboratory, and quality systems within a regulated pharmaceutical or biotechnology environment.
- Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11.
- Strong knowledge of risk-based validation and CSA principles.
- Strong knowledge of Software Development Lifecycle (SDLC) processes.
- Strong knowledge of change management and deviation processes.
- Experience supporting capital projects and Good Manufacturing Practice (GMP) computerized systems.
- Strong stakeholder management and communication skills.
- Ability to work independently across multiple projects and sites.
- Ability to commute to the site in Rahway, NJ approximately three days per week.
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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.
