Senior Process Engineer: Validation, Equipment & Transfers

Intepros; Kalamazoo (MI); On-site; USD 85,000 - 125,000; Full time

Job summary

Intepros in Kalamazoo, MI is seeking a Senior Process Engineer to support validation, equipment integration and product transfers in a medical device manufacturing setting.

The role emphasizes hands-on data analysis, cross-functional collaboration, and strict GMP compliance. You will lead validation activities, develop PFMEAs, Control Plans, and PPAPs, drive process improvements across manufacturing lines, mentor junior engineers, and support tech transfers in a fast-paced medical device setting.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 4+ years of relevant engineering experience in medical devices.
• Experience with process and equipment validation, PPAP, and equipment integration.
• Knowledge of Six Sigma and statistical methods.
• Strong problem-solving and cross-functional collaboration skills.

Responsibilities

• Execute process validation activities, including data collection and reporting.
• Set up, troubleshoot, and optimize manufacturing equipment and fixtures.
• Collaborate with Quality, Operations, Engineering, Materials, and other teams for production readiness.
• Develop and review process qualification documentation (PFMEAs, Control Plans, SOPs, PPAPs).
• Lead or review process review meetings and manage project workstreams.
• Support product transfers and cost-improvement initiatives while maintaining GMP compliance.

Skills

Process validation

Equipment integration

Six Sigma

Statistical methods

Project management

Cross-functional collaboration

GMP compliance

Data analysis

Manufacturing

Problem solving

Education

Bachelor's degree in Engineering

Job description

Intepros in Kalamazoo, MI is seeking a Senior Process Engineer to support validation, equipment integration and product transfers in a medical device manufacturing setting.

The role emphasizes hands-on data analysis, cross-functional collaboration, and strict GMP compliance. You will lead validation activities, develop PFMEAs, Control Plans, and PPAPs, drive process improvements across manufacturing lines, mentor junior engineers, and support tech transfers in a fast-paced medical device setting.