Validation Engineer - 168478

About the role

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. This is a long-term contract role requiring onsite work five days per week in Clayton, NC, supporting facility startup, operational readiness, and regulatory compliance initiatives.

Responsibilities

• 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

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 5+ years of CQV/Validation experience within a pharmaceutical, biotechnology, or sterile manufacturing environment.
• 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

$155,000 to $175,000 paid at an hourly rate of $75/hr – $84/hr.

Benefits

• Health insurance
• Vision insurance
• Dental insurance
• Paid time off (PTO)
• Paid holidays
• Sick leave (if required by law)

Schedule

Onsite work five days per week in Clayton, NC.