Validation Engineer - 175655

About the role

Piper Companies is seeking a Validation Engineer for a leading pharmaceutical manufacturing organization in Clayton, NC. 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

• 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

• 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.

Benefits

• Health insurance
• Vision insurance
• Dental insurance
• PTO
• Paid holiday
• Sick leave (if required by law)

Pay

$130,000 - $160,000 annually

Schedule

Fully onsite in Clayton, NC. 2-year contract engagement with potential extension opportunities.