Process Engineer in Kalamazoo

Energy Jobline ZR; Kalamazoo (MI); On-site; USD 70,000 - 120,000; Full time

Job summary

Energy Jobline ZR in Kalamazoo, MI is seeking an Equipment Validation Engineer to support process validation through sampling, data analysis, and documentation in validation reports. You will collaborate with Quality, Operations and Engineering to ensure processes meet requirements and to drive improvements as products move into production.

The role involves setting up and troubleshooting manufacturing equipment, participating in PPAP, PFMEA, and SOP activities, and ensuring GMP and safety

Qualifications

• Engineering degree with 4 years of experience in validation or manufacturing.
• Medical industry experience strongly preferred.
• PPAP, PFMEA, and Control Plan experience required.
• GMP and safety procedures knowledge essential.

Responsibilities

• Run samples on manufacturing equipment to support process validation and document results in validation reports.
• Collaborate with Quality, Operations and Engineering to ensure processes meet requirements and drive improvements.
• Set up components, fixtures, tooling, and equipment on the assembly line; troubleshoot during builds.
• Support PPAP activities, SOP development, and process qualification across product transfers.
• Assist materials team to ensure line readiness for components/materials and maintain cross-functional communication.

Skills

PPAP

Six Sigma

Statistical analysis

Process validation

Cross-functional collaboration

Education

Engineering degree

Tools

IQ/OQ/PQ documentation

PFMEA

Control Plan

Job description

Job DescriptionJob Description

Job Description:

This role would spend much of the day supporting process validation activities by running samples on manufacturing equipment, collecting and analyzing data, and documenting results in validation reports.

They would work closely with Quality, Operations, and Engineering teams to ensure processes meet requirements.

In addition, they would help set up components, fixtures, tooling, and equipment on the assembly line, troubleshoot issues during builds, and support process improvements as products move into production.

Assist and collaborate with materials team to make sure the line is set up to receive components/raw materials.

Overall, the position combines hands-on manufacturing support with technical documentation and cross-functional collaboration

The role contributes to the delivery of high impact, cost transformative projects.

The role will require the successful candidate to operate across a network of stakeholders from Product Transfer, Operations and Divisional partners, therefore strong interpersonal skills and communication skills will be necessary.

Position will require PPAP skills, analyze equipment to establish operating data, conduct experimental test and result analysis.

May lead or act as independent reviewer in process review meetings.

Participate in PFMEA, Control Plan, SOP, PPAP and other internal process qualification associated with product transfers.

Ensure adherence to GMP and safety procedures.

Equipment Validation Experience.

Statistical methods for process development.

Manufacturing/Test Equipment Integration & Troubleshooting

PPAP experience, ability to manage a workstream and its tasks, Complex problem solving, Six Sigma/continuous improvement

Engineering degree, 4 years experience

Medical industry experience STRONGLY

You will primarily support equipment validation, including torque screw applications and other specialized equipment. Additional responsibilities include IQ/OQ/PQ documentation, work instructions, PPAP support, process planning, material labeling, hand-tool setup, and equipment troubleshooting/integration.

Medical, Dental and Vision are provided for those who qualify and are eligible.