Senior CSV Analyst

Requirements:

• At least 5 years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), automation compliance, shopfloor, enterprise, laboratory, or quality systems in a regulated pharmaceutical or biotechnology environment.
• Experience with CSV for manufacturing automation systems such as DeltaV, PI Historian, PLC, or laboratory 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.
• Demonstrated experience supporting capital projects and GMP computerized systems.
• Strong stakeholder management and communication skills.
• Ability to work independently across multiple projects and sites.

Responsibilities:

• Lead computer system validation (CSV) compliance activities for capital and strategic projects.
• Develop, review, and approve validation lifecycle deliverables in accordance with applicable SOPs and regulatory requirements, including 21 CFR Part 11.
• Advise project teams on SDLC, CSA, qualification, and validation approaches.
• Participate in project meetings and CSV compliance reviews.
• Support project change controls and CSV compliance-related risk assessments.
• Maintain project CSV compliance trackers, metrics, and reports.
• Approve SDLC documents as part of the technical unit.

Technologies:

• Support
• PLC
• Security

More

We offer a role leading CSV compliance activities, with a pay range of $45–$50 per hour. Our benefits include medical, dental, and vision insurance; a 401(k); a health savings account; short- and long-term disability insurance; life and AD&D insurance; paid sick leave where required by law; supplemental insurance plans; identity theft protection; pet insurance; wellness programs; an employee assistance program; and career development opportunities. Benefit eligibility and terms may vary by employment status, service length, and location, and plans may change in accordance with applicable laws. Founded in 2010 and headquartered in the Washington, DC metro area, we are Cynet Systems Inc., a technology staffing and workforce solutions company serving organizations across the United States and Canada. We provide staffing solutions across IT, engineering, life sciences, clinical, and professional fields, and hold MBE, ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II certifications.

last updated 43 week of 2026