Lead Computer System Validation Engineer

Job Title: Lead Computer System Validation Engineer

Job Location: Durham, NC

Job Type: Contract

Pay Range: $50.00hr - $55.00hr

Job Overview:

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.

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.

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.

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• 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