Senior Validation Engineer

Piper Companies is seeking a Senior Validation Engineer to join a rapidly growing biotechnology manufacturing organization for an onsite contract position located in Clayton, NC
. The Senior Validation Engineer will lead validation activities for automated manufacturing systems, equipment, and processes while supporting large-scale pharmaceutical production projects in a regulated GMP environment.

• Lead the development, execution, analysis, and reporting of Installation Verification (IV), Operational Verification (OV), and Performance Verification (PV) protocols for manufacturing equipment and processes.
• Manage validation-related change controls, review protocol documentation, and ensure all activities meet regulatory and site quality standards.
• Author and maintain validation plans, project quality documentation, procedures, specifications, and supporting records required to sustain a validated state.
• Drive investigations associated with validation deviations, failures, and nonconformances using structured root cause analysis methodologies.
• Support FAT, SAT, commissioning, and startup activities while coordinating validation project schedules, contractors, and cross-functional stakeholders.

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline; advanced degree preferred.
• 7+ years of validation experience within pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• Strong knowledge of GMP requirements, FDA regulations, 21 CFR Part 11, GAMP 5, ICH guidelines, and computerized system validation principles.
• Demonstrated experience with automated manufacturing equipment validation, change management, and complex root cause investigations.
• Proven project leadership skills with the ability to manage multiple initiatives, technical documentation, timelines, and cross-functional teams.

Salary Range: $74-$84/hr (USD)

• Comprehensive Benefits:
  Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 9/30/26. Applications for this job will be accepted for at least 30 days from the posting date.

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