Senior Validation Engineer - GMP Process & Equipment Lead

Piper Companies; Durham (NC); On-site; USD 96,000 - 110,000; Full time

Job summary

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client in a GMP environment. This role focuses on validation activities across fill/finish operations, equipment qualification, process validation, and compliance initiatives.

Based onsite in Clayton, NC, you will drive validation strategy, execute IQ/OQ/PQ protocols, lead investigations and deviations, and oversee change control, documentation, and continuous improvement for critical

Qualifications

• Bachelor's degree in engineering, computer science, or a related technical field; equivalent experience considered.
• Master's degree preferred.

Responsibilities

• Provide validation and technical support through IQ/OQ/PQ protocols.
• Own Change Requests related to validation activities and project deliverables.
• Author and review Validation Plans, PQMPs, protocols, reports, and validation documentation.
• Execute validation activities for direct-impact systems, equipment, and processes.
• Perform compliance reviews and technical approvals of protocols, reports, and validation data.
• Lead validation investigations, deviations, and non-conformances using root cause analysis.
• Ensure validation activities comply with local, corporate, and regulatory requirements.
• Create and revise validation procedures, CILs, specifications, and SOPs.
• Support FAT, SAT, commissioning, qualification, and startup activities.
• Identify process improvements and support continuous improvement initiatives.
• Provide contractor oversight, project coordination, and budget support.
• Lead validation activities and serve as SME for new systems and equipment implementations.

Skills

Leadership

Cross-functional collaboration

Root cause analysis

Technical writing

Education

Bachelor's degree in Engineering/CS or related

Master's degree preferred

Job description

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client in a GMP environment. This role focuses on validation activities across fill/finish operations, equipment qualification, process validation, and compliance initiatives.

Based onsite in Clayton, NC, you will drive validation strategy, execute IQ/OQ/PQ protocols, lead investigations and deviations, and oversee change control, documentation, and continuous improvement for critical