Process Validation EngineerManufacturing Engineer Medical Device

Job Title: Senior Process Validation Engineer

Location: Raynham MA (Onsite Local candidates preferred)

Type: Contract (1 year long-term extensions)

Industry: Medical Device Manufacturing Supply Chain Quality

Job Summary:

We are seeking a Senior Process Validation Engineer to support the startup and qualification of a new Class III medical device manufacturing facility. This role will be part of the Supply Chain Quality team and will lead critical validation and quality activities to ensure compliant and efficient manufacturing operations.

The ideal candidate will bring strong expertise in process validation equipment qualification and inspection readiness working closely with cross-functional teams in a highly regulated environment.

Key Responsibilities

• Lead process qualification and validation activities to ensure manufacturing processes are robust and compliant
• Plan and execute IQ OQ PQ and process validation activities
• Develop validation strategies protocols reports and documentation (including URS)
• Support inspection readiness by ensuring Critical-to-Quality (CTQ) characteristics are verified using qualified methods
• Perform test method validation and measurement system analysis (e.g. Gauge R&R)
• Provide Quality oversight for validation documentation and approvals
• Support deviation investigations root cause analysis and troubleshooting
• Collaborate with Manufacturing Engineering Supply Chain and R&D teams to meet project timelines

Required Qualifications

• 5 years of hands-on experience in process validation within regulated environments (GMP/ISO)
• 4 years of experience in Quality Supply Chain or R&D within medical devices or similar industries
• Strong expertise in IQ/OQ/PQ process verification and validation documentation
• Experience with CNC machining processes and Coordinate Measuring Machines (CMM)
• Experience in risk management (FMEA)
• Strong communication collaboration and project management skills