Senior Process Engineer

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.