Validation Engineer

Piper Companies is seeking a Validation Engineer to support a leading pharmaceutical manufacturing organization in a highly regulated environment. The Validation Engineer will play a critical role in ensuring GMP compliance through hands-on equipment qualification, validation activities, and cross-functional collaboration within sterile manufacturing operations.

Responsibilities of the Validation Engineer:

• Execute commissioning, qualification, and validation (CQV) activities for GMP equipment, utilities, and automated systems.
• Author, review, and execute IQ/OQ/PQ protocols and validation summary reports.
• Support validation efforts across systems including material handling, automated inspection, and sterilization equipment.
• Perform validation activities for washers, autoclaves, SIP/CIP systems, and aseptic processing equipment.
• Assist in validation of formulation, mixing, filling lines, isolators, RABS, and lyophilization systems.
• Troubleshoot validation issues and support deviation investigations and corrective actions.
• Collaborate with engineering, quality, and manufacturing teams to ensure compliance with regulatory requirements.
• Ensure adherence to FDA GMP regulations, EU GMP Annex 1, and industry validation standards.
• Maintain clear, thorough, and audit-ready documentation for all validation activities.

Qualifications of the Validation Engineer:

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 3+ years of CQV/Validation experience within pharmaceutical, biotechnology, or sterile manufacturing environments.
• Hands-on experience qualifying GMP equipment, utilities, and automated systems.
• Direct experience with one or more systems including material handling, automated inspection, sterilization equipment, or aseptic processing lines.
• Strong working knowledge of FDA GMP regulations, EU GMP Annex 1, and validation best practices.
• Proven experience authoring and executing IQ/OQ/PQ protocols and reports.
• Strong technical writing, troubleshooting, and cross-functional communication skills.

Compensation for the Validation Engineer includes:

• Salary range: $130,000 - $150,000 depending on experience
• Comprehensive benefits package including medical, dental, vision, 401(k), and PTO
• Onsite work environment (5 days per week in Clayton, NC)

This job opens for applications on 07/17/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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