Senior Process Validation Engineer
Medical Device Manufacturing | Supply Chain Quality

Location: Raynham, Mass *LOCAL CANDIDATES ONLY, please include your location on your resume.

Contract: 1 year plus long term contract.

We are seeking a Senior Process Validation Engineer to support the build‑out and qualification of a new Class III medical device manufacturing facility. This role sits within the Supply Chain Quality organization and will play a critical role in defining, leading, and executing validation and quality activities required for successful facility start‑up and ongoing operations.

This position offers the opportunity to work cross‑functionally on equipment and process qualification, inspection readiness, and new product and process introduction in a highly regulated environment.

Required Qualifications

• Four or more years of experience in Supply Chain, Quality, and/or Research and Development within a regulated GMP or ISO environment
• Five or more years of hands‑on process validation experience
• Strong experience leading process verification and validation activities, including IQ, OQ, PQ, and test method validation
• Deep expertise in process validation principles and documentation
• Experience validating processes involving CNC machining and Coordinate Measuring Machines
• Experience leading risk management activities, including development of Failure Modes and Effects Analysis
• Strong collaboration, communication, and technical leadership skills
• Proven ability to manage multiple priorities and drive projects to completion

Key Responsibilities

• Lead manufacturing process qualification and validation activities, ensuring processes are capable and compliant
• Plan and execute process verification and validation efforts, including IQ, OQ, and PQ
• Develop validation strategies, protocols, reports, and supporting documentation such as User Requirements Specifications
• Lead inspection planning to ensure all Critical‑to‑Quality characteristics are verified using qualified inspection and test methods
• Execute test method validation and measurement system analysis, including Gauge Repeatability and Reproducibility
• Provide Quality oversight for documentation, records, and activities requiring formal Quality review or approval
• Support deviation investigations, troubleshooting, and root cause analysis during project execution
• Partner cross‑functionally with Manufacturing, Engineering, Supply Chain, and Research and Development teams to meet project timelines and objectives

Preferred Qualifications

• Advanced degree or background in Engineering, Science, Computer Science, or a technical discipline
• Quality Engineering experience
• Experience with CNC machining processes
• Experience with inspection and test methods, including Geometric Dimensioning and Tolerancing
• Experience working with Manufacturing Execution Systems and quality workflows
• Strong background in Lean, Six Sigma, or continuous improvement methodologies