Onsite Senior Validation Engineer, Pharma GMP Leader

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

Benefits offered by this job

Competitive hourly pay

Benefits package: medical, dental, and

Long-term contract with project impact

Job summary

Piper Companies is seeking a Senior Validation Engineer to lead validation activities within a GMP environment, supporting fill/finish operations and equipment qualification. The role focuses on strategy, execution, investigations, and change management across critical manufacturing systems.

This long-term W2 contract requires onsite presence five days a week in Clayton, NC, offering a highly visible position to drive validation efforts from commissioning through process qualification.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline; equivalent experience will be considered.
• Master’s degree preferred.
• 7+ years of validation, quality, or related experience in pharma or medical device industries.
• Strong GMP knowledge and validation lifecycle experience.
• Experience with 21 CFR Part 11, GAMP5, ISO standards, FDA regulations, and ICH guidance.

Responsibilities

• Prepare, execute, analyze, and report IQ/OQ/PQ validation protocols.
• Own change requests related to validation activities and project deliverables.
• Author and review validation plans, PQMPs, protocols and validation documents.
• Execute validation activities for critical systems, equipment, and processes to meet timelines.
• Perform compliance reviews and technical approvals of validation data and reports.
• Lead investigations, deviations, and CAPA using root cause methods.
• Ensure validation activities comply with regulatory requirements.
• Create/update validation procedures, CILs, specifications, and SOPs as needed.
• Support FAT, SAT, commissioning, qualification, and startup activities for equipment and processes.
• Identify process improvements and provide contractor oversight and budget support.

Skills

Leadership

Cross-functional collaboration

Project management

Regulatory compliance

Root cause analysis

Education

Bachelor’s degree in Engineering or related field

Master’s degree preferred

Job description

Piper Companies is seeking a Senior Validation Engineer to lead validation activities within a GMP environment, supporting fill/finish operations and equipment qualification. The role focuses on strategy, execution, investigations, and change management across critical manufacturing systems.

This long-term W2 contract requires onsite presence five days a week in Clayton, NC, offering a highly visible position to drive validation efforts from commissioning through process qualification.