Process Validation Engineer/Manufacturing 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