Senior Validation Engineer

Sr. Validation Engineer – Wilson, NC (Onsite Only)

Long Term Contract

We’re seeking an experienced Sr. Validation Engineer to support ongoing commissioning, qualification, and validation activities at a large-scale pharmaceutical manufacturing site in Wilson, NC. This role requires strong hands-on experience with equipment and automation system qualification, excellent documentation discipline, and the ability to work cross-functionally in a cGMP-regulated environment.

Responsibilities

• Lead and execute DQ, IQ, OQ, and PQ protocols for equipment, utilities, and automation systems.
• Support commissioning and qualification activities across new and existing systems.
• Develop validation plans, risk assessments, test protocols, traceability matrices, and final reports.
• Ensure all activities comply with cGMP, FDA, ICH, and EU regulatory standards.
• Utilize digital validation tools such as Kneat, GVault, or equivalent platforms to manage and execute validation documentation.
• Collaborate closely with engineering, quality, operations, and automation teams.
• Troubleshoot validation issues, perform gap assessments, and support remediation efforts.
• Maintain accurate documentation and ensure audit readiness for regulatory inspections.
• Coordinate project timelines, deliverables, and progress updates with internal stakeholders.

Required Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related discipline.
• Minimum 7 years of validation experience within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in DQ/IQ/OQ/PQ execution.
• Strong knowledge of cGMP, FDA, ICH, and EU regulations.
• Proven experience with commissioning and qualification of equipment or automation systems.
• Proficiency with validation software tools such as Kneat or GVault.
• Excellent communication, documentation, and project coordination skills.
• Ability to work onsite full-time in Wilson, NC.