Validation Engineer

Piper Companies is hiring a Validation Engineer for a pharmaceutical manufacturing company located in Clayton, NC. The Validation Engineer will support CQV activities for a sterile fill-finish manufacturing facility, with responsibility for qualification and validation efforts across Material Handling, Inspection, Wash & Sterilization, Formulation, and Filling systems. The Validation Engineer is a long-term contract role that will work onsite 5 days per week in Clayton, NC, supporting facility startup, operational readiness, and regulatory compliance initiatives.

Responsibilities of the Validation Engineer:

• Author, review, and execute commissioning, qualification, and validation documentation, including IQ/OQ/PQ protocols and summary reports.
• Perform risk assessments, manage deviations and CAPAs, and maintain traceability documentation throughout validation activities.
• Partner with Engineering, Quality, Manufacturing, Automation, and vendor teams to support equipment qualification and facility startup.
• Ensure GMP compliance while supporting process validation, sterilization qualifications, equipment startup, and regulatory inspection readiness.

Requirements of the Validation Engineer:

• Bachelor's degree in Engineer, Life Sciences, or a related technical field.
• 5+ years of CQV / Validation experience within a pharmaceutical, biotechnology, or sterile manufacturing environments.
• Experience qualifying GMP equipment, utilities, automated systems, and authoring/executing IQ/OQ/PQ protocols and validation reports.
• Working knowledge of FDA GMP regulations, EU GMP Annex 1, and hands-on experience with material handling, inspection, wash/sterilization, formulation, or aseptic filling systems.

Compensation for the Validation Engineer:

• $155,000 to $175,000 paid at an hourly rate of $75/hr - $84hr
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law

Keywords: Validation Engineer, CQV, Commissioning, Qualification, Validation, GMP, FDA, EU Annex 1, IQ, OQ, PQ, Sterile Manufacturing, Fill Finish, Aseptic Processing, Equipment Qualification, Pharmaceutical Manufacturing, Biotechnology, CAPA, Risk Assessment, Process Validation

This job opens for applications on 6/25/26. Applications for this job will be accepted for at least 30 days from the posting date.

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