Senior Validation Engineer – GMP Pharma, Onsite

Piper Companies; Clayton (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 Clayton, NC. This role focuses on validation activities within a regulated GMP environment, covering IQ/OQ/PQ protocols, equipment qualification, and process validation.

The Senior Validation Engineer will lead validation strategy and execution, drive investigations, change management, and collaborate across manufacturing systems and processes to ensure compliance and project

Qualifications

• Bachelor’s degree in Engineering or related field; equivalent experience considered.
• Master’s degree preferred.
• 7+ years of validation, quality, or related experience in pharma/medical devices.
• Strong GMP knowledge and validation lifecycle experience.

Responsibilities

• Prepare, execute, analyze IQ/OQ/PQ protocols and reports.
• Own change requests related to validation activities.
• Author and review validations documents (VPLs, PQMPs, protocols, reports).
• Lead validation investigations and non-conformances with root cause analysis.
• Ensure compliance with regulatory requirements and change control processes.

Skills

Project leadership

Communication

Root cause analysis

Technical writing

Process improvement

Education

Bachelor’s degree in Engineering or related field

Master’s degree preferred

Tools

GAMP5

21 CFR Part 11

FDA regulations

ICH guidance

ISO standards

Job description

Piper Companies is seeking a Senior Validation Engineer to support a leading pharmaceutical manufacturing client in Clayton, NC. This role focuses on validation activities within a regulated GMP environment, covering IQ/OQ/PQ protocols, equipment qualification, and process validation.

The Senior Validation Engineer will lead validation strategy and execution, drive investigations, change management, and collaborate across manufacturing systems and processes to ensure compliance and project