Lead Computer System Validation Engineer

Cynet Systems • Durham, NC

2d

About The Position

The Lead Computer System Validation (CSV) Specialist provides hands-on validation and compliance support for computerized manufacturing systems within a regulated pharmaceutical environment. This role focuses primarily on CSV compliance, SDLC, CSA, validation governance, and quality compliance across capital and strategic projects.

Requirements

• Must have experience working in CSV for manufacturing automation systems, such as DeltaV DCS, PI Historian, PLC systems (Rockwell and/or Siemens), or Laboratory Automation Systems.
• Hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment.
• Strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical/manufacturing environments.
• Familiarity with Kneat, ServiceNow (SNOW), and Veeva Systems.
• Knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.
• Experience reviewing and approving validation documentation and compliance deliverables.
• Familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements.
• Experience with validation, qualification, change control, risk assessments, and lifecycle compliance activities associated with manufacturing and laboratory computerized systems.
• Understanding of GxP, Data Integrity, CSV/CSA, and SDLC requirements for manufacturing automation platforms.

Responsibilities

• Provide CSV compliance support for capital and strategic projects to ensure continuity of compliance oversight and project delivery.
• Develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.
• Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed