Process Validation Engineer: IQ/OQ/PQ & GMP Impact

United Pharma; Michigan; On-site; USD 85,000 - 130,000; Full time

Job summary

United Pharma seeks a Process Validation Engineer to support validation activities for a leading medical device organization in Portage, Michigan. You will execute IQ/OQ/PQ, analyze data, prepare documentation, and troubleshoot equipment.

Ideal candidates will assist with product transfers, process improvements, and cross-functional engineering initiatives while ensuring GMP, quality, and safety compliance. Strong communication and documentation skills are essential.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Experience with manufacturing or test equipment.
• Knowledge of equipment validation and IQ/OQ/PQ.
• Medical device manufacturing experience preferred.
• Strong troubleshooting and cross-functional communication.
• Familiarity with PPAP, PFMEA, and Control Plans.
• GMP, quality, and safety compliance.

Responsibilities

• Execute IQ/OQ/PQ validation activities.
• Run manufacturing samples, analyze data, and prepare validation reports.
• Set up and troubleshoot manufacturing equipment, fixtures, tooling, and assembly processes.
• Support product transfers, process improvements, and manufacturing equipment integration.
• Develop and review PFMEA, Control Plans, SOPs, and PPAP documentation.
• Apply statistical methods to evaluate process performance and support continuous improvement.
• Collaborate with Quality, Engineering, Operations, and Materials teams to ensure GMP and safety compliance.

Skills

Troubleshooting

Cross-functional comm

Statistical analysis

Documentation

GMP knowledge

Education

Bachelor’s degree in Engineering

Tools

IQ/OQ/PQ protocols

PPAP

PFMEA

Control Plans

Job description

United Pharma seeks a Process Validation Engineer to support validation activities for a leading medical device organization in Portage, Michigan. You will execute IQ/OQ/PQ, analyze data, prepare documentation, and troubleshoot equipment.

Ideal candidates will assist with product transfers, process improvements, and cross-functional engineering initiatives while ensuring GMP, quality, and safety compliance. Strong communication and documentation skills are essential.