Senior CSV Analyst

Pay Range: $45.00hr - $50.00hr Job Overview: The candidate will lead computer system validation (CSV) compliance activities for capital and strategic projects. Experience working with CSV in manufacturing automation systems such as DeltaV, PI Historian, PLC, or Lab Automation Systems is required. 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 the 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 part of the technical unit. Requirements: Minimum 5 years of experience in Computer System Validation (CSV), CSA, Automation Compliance, Shopfloor, Enterprise, Lab, and Quality Systems within a regulated pharmaceutical or biotechnology environment. Experience working in CSV for manufacturing automation systems such as DeltaV, PI Historian, PLC, or Lab Automation Systems. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, risk-based validation, and CSA principles. Solid understanding of the Software Development Life Cycle (SDLC), Change Management, and Deviation processes. Proven 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. 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.