Senior Process Validation Engineer - Medical Devices

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

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.