Senior Validation Engineer (CQV)

Job Title: CQV Validation Engineer

Location: Raleigh, NC (100% Onsite)

Duration: Long-Term Project Assignment

Position Summary

We are seeking a Validation Engineer with 3 years of experience to support Commissioning, Qualification, and Validation (CQV) activities for a large-scale pharmaceutical/biotech project in Raleigh, NC. The role will focus on end-to-end CQV execution for critical systems and equipment, ensuring compliance with FDA, cGMP, and industry standards.

Key Responsibilities

• Develop and execute Commissioning, Qualification, and Validation (CQV) protocols including FAT, SAT, IQ, OQ, and PQ.
• Lead CQV activities for process equipment, utilities, HVAC systems, and laboratory instrumentation.
• Prepare validation documentation including protocols, summary reports, traceability matrices, and risk assessments.
• Collaborate with Engineering, Quality, and Manufacturing teams to ensure timely and compliant project execution.
• Support development of commissioning and validation plans, schedules, and test scripts.
• Ensure adherence to cGMP, FDA, and ISPE guidelines throughout CQV activities.
• Address deviations, perform root cause analysis, and support CAPA implementation.
• Maintain validation deliverables to ensure audit readiness and compliance with regulatory inspections.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
• 3 years of experience in CQV within pharmaceutical, biotech, or medical device industries.
• Strong knowledge of cGMP, FDA regulations, and ISPE Baseline Guides for CQV.
• Hands-on experience with utilities, HVAC, process equipment, and laboratory systems.
• Proficient in protocol development, execution, and documentation of IQ/OQ/PQ activities.