Process Validation Engineer/Manufacturing Engineer - Medical Device

Stark Pharma; Raynham (MA); On-site; USD 80,000 - 110,000; Part time

Job summary

Stark Pharma is seeking a Senior Process Validation Engineer in Raynham, MA. This role involves leading critical validation activities for a new Class III medical device manufacturing facility. Candidates should have over 5 years of experience in process validation within regulated environments, with an emphasis on quality assurance and collaboration with various teams. This position is contract-based with potential for long-term extensions and requires strong communication, problem-solving skills, and a solid understanding of regulatory standards.

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.
• Strong expertise in IQ/OQ/PQ, process verification, and validation documentation.

Responsibilities

• Lead process qualification and validation activities to ensure manufacturing processes are robust.
• Develop validation strategies, protocols, reports, and documentation.
• Collaborate with Manufacturing, Engineering, Supply Chain, and R&D teams.

Skills

Process validation

Quality oversight

Project management

Risk management (FMEA)

CNC machining processes

Strong communication

Tools

Coordinate Measuring Machines (CMM)

Job description

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