The Validation Engineer role requires working fully onsite in Clayton, NC. The Validation Engineer role is ideal for an experienced validation professional with expertise supporting GMP-regulated environments across manufacturing operations, facility systems, quality control laboratories, and computerized systems.
Responsibilities of the Validation Engineer include:
• Lead commissioning, qualification, and validation activities for facility systems, manufacturing equipment, and supporting utilities within GMP-regulated operations.
• Develop, execute, and review validation documentation including IQ/OQ/PQ protocols, validation plans, risk assessments, and final summary reports.
• Support validation efforts across aseptic formulation and filling, device assembly and packaging, warehouse operations, QC laboratories, and computerized systems.
• Partner with engineering, quality assurance, manufacturing, IT, and operations teams to ensure validation deliverables meet project timelines and regulatory expectations.
• Investigate protocol deviations, implement corrective actions, and maintain compliance with FDA, EU GMP, and industry validation standards.
Requirements of the Validation Engineer include:
• 5+ years of validation experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Hands-on experience supporting commissioning, qualification, and validation (CQV) projects for facility systems, manufacturing processes, or computerized systems.
• Knowledge of aseptic processing, filling operations, packaging systems, warehouse validation, and/or QC laboratory validation.
• Familiarity with cGMP regulations, FDA guidance, GAMP 5, and data integrity requirements.
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
Compensation for the Validation Engineer include:
• $130,000 - $160,000 annually
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.
• 2-year contract engagement with potential extension opportunities.
• This job opens for applications on 10/02/2026. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: validation engineer, CQV engineer, commissioning engineer, qualification engineer, aseptic manufacturing, GMP, facility systems, IT systems validation, computer systems validation, CSV, QC validation, warehouse validation, packaging validation, pharmaceutical manufacturing
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