Senior Process Engineer

GForce Life Sciences; Kalamazoo (MI); On-site; USD 90,000 - 120,000; Full time

Job summary

GForce Life Sciences seeks a Senior Engineer, Process Engineering - Individual Contributor, to support process validation activities and collaborate with cross-functional teams in the medical manufacturing space.

You will help set up equipment, analyze data, and contribute to process improvements while ensuring GMP compliance and product readiness across transfers.

Qualifications

• Engineering degree with at least 4 years of experience in process engineering or validation.
• Experience in equipment validation and statistical methods for process development.
• PPAP experience, including managing workstreams and equipment analysis.
• Ability to conduct experimental tests and analyze results.
• Experience with PFMEA, Control Plan, SOP, and process qualification activities.
• Knowledge of GMP and safety procedures.

Responsibilities

• Support process validation activities by running samples on manufacturing equipment and documenting results.
• Collaborate with Quality, Operations, and Engineering to 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 to production.
• Coordinate with materials teams to ensure line readiness for components and raw materials.
• Participate in process reviews, PFMEA, Control Plan, SOP, and PPAP generation for product transfers.
• Engage with stakeholders from Product Transfer, Operations, and Divisional partners.
• Conduct experimental testing and analyze data to establish operating data.
• Ensure adherence to GMP and safety procedures.
• Lead or serve as independent reviewer in process review meetings.
• Manage workstreams and tasks related to equipment validation and statistical analysis.

Skills

Process validation

Statistical methods

Troubleshooting

GMP knowledge

Cross-functional collaboration

Data analysis

Process optimization

Education

Engineering degree

Job description

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.