Senior Validation Engineer - Onsite GMP Lead (Clayton)

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

Job summary

Piper Companies seeks a Senior Validation Engineer to drive validation strategy in a GMP pharmaceutical environment, supporting fill/finish operations and equipment qualification.

The role is a long-term W2 contract onsite in Clayton, NC, with responsibility for IQ/OQ/PQ, change control, investigations, and continuous improvement across manufacturing systems. 7+ years of experience and strong regulatory knowledge are required.

Qualifications

• Bachelor's degree required in engineering, computer science or related field.
• Master's degree preferred depending on experience.
• 7+ years in pharma/medical device validation or quality.
• Strong GMP knowledge (21 CFR Part 11, GAMP5, FDA/ICH).

Responsibilities

• Prepare, execute, analyze IQ/OQ/PQ protocols and reports.
• Own change requests and validation documentation.
• Develop and review VPLs, PQMPs, SOPs, and validation docs.
• Lead validation activities for critical systems and equipment.
• Support commissioning, FAT/SAT, and startup activities.
• Identify process improvements and drive continuous improvement.
• Provide contractor oversight and budgeting support.
• Serve as SME for new systems implementations.

Skills

Regulatory knowledge

Cross-functional leadership

Documentation skills

Project management

Education

Bachelor's degree in Engineering/CS or related field

Master's degree preferred

Job description

Piper Companies seeks a Senior Validation Engineer to drive validation strategy in a GMP pharmaceutical environment, supporting fill/finish operations and equipment qualification.

The role is a long-term W2 contract onsite in Clayton, NC, with responsibility for IQ/OQ/PQ, change control, investigations, and continuous improvement across manufacturing systems. 7+ years of experience and strong regulatory knowledge are required.