Validation Engineer - 176116

About the role

Piper Companies is seeking a Validation Engineer to join a leading pharmaceutical manufacturing organization for a long-term onsite contract opportunity based in Clayton, NC. The Validation Engineer will support a diverse project portfolio across manufacturing, facilities, laboratory, automation, and quality systems while ensuring compliance with regulated industry standards.

Responsibilities

• Develop, revise, and maintain validation lifecycle documentation including validation plans, specifications, risk assessments, traceability matrices, reports, and change control records.
• Author and execute qualification and validation activities such as IQ, OQ, PQ, design reviews, commissioning support, and process validation for manufacturing and facility-based projects.
• Partner with project managers, engineering teams, quality personnel, and vendors to support equipment upgrades, facility modifications, automation initiatives, and technology modernization efforts.
• Investigate deviations, assess validation impacts, document corrective actions, and support change management activities throughout project execution.
• Ensure all validation deliverables meet GMP requirements and align with FDA regulations, GAMP 5 principles, Annex 15 guidance, and internal quality procedures.

Qualifications

• 5+ years of validation experience within a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Hands-on experience supporting manufacturing equipment, aseptic processing systems, packaging operations, laboratory environments, utilities, or facility infrastructure projects.
• Knowledge of computerized systems validation and familiarity with platforms such as SCADA, PLCs, PAS-X, LMES, Veeva, HP ALM/TIMS, or similar regulated systems.
• Experience authoring and executing qualification protocols, validation reports, risk assessments, and electronic validation documentation with minimal supervision.
• Bachelor’s degree in Engineering, Life Sciences, Computer Systems, or a related technical discipline.

Pay

Salary Range: $71-$81/hr (USD)

Benefits

• Medical
• Dental
• Vision
• Sick leave (if required by law)
• 401K