Senior Process Engineer

Senior Process Engineer

12-Month Contract

Onsite in Kalamazoo, MI

SUMMARY Our client, a company within the medical industry, has engaged GForce Life Sciences to provide a Senior Engineer, Process Engineering – Individual Contributor. This position will support process validation activities, collaborate with cross-functional teams, and contribute to process improvements for manufacturing products.

RESPONSIBILITIES

Support process validation activities by running samples on manufacturing equipment, collecting and analyzing data, and documenting results in validation reports. Work closely with Quality, Operations, and Engineering teams to ensure processes meet requirements. Assist in setting up components, fixtures, tooling, and equipment on the assembly line. Troubleshoot issues during builds and support process improvements as products move into production. Collaborate with materials teams to ensure line readiness for receiving components and raw materials. Participate in process reviews, PFMEA, Control Plan, SOP, and PPAP generation associated with product transfers. Operate across stakeholders from Product Transfer, Operations, and Divisional partners, requiring strong communication skills. Conduct experimental testing, analyze equipment to establish operating data, and support validation efforts. Ensure adherence to GMP and safety procedures. Lead or serve as an independent reviewer in process review meetings. Manage workstreams and tasks related to equipment validation, statistical analysis, and process development.

MANDATORY REQUIREMENTS

Engineering degree with at least 4 years of experience in process engineering or validation. Experience in equipment validation, statistical methods for process development, and manufacturing/test equipment troubleshooting. PPAP experience, including managing workstreams and performing equipment analysis. Ability to conduct experimental tests and analyze results. Strong problem-solving skills, with experience in complex troubleshooting. Experience participating in PFMEA, Control Plan, SOP, and process qualification activities. Knowledge of GMP and safety procedures. Medical industry experience is strongly preferred.

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