Process Validation Engineer

United Pharma; Michigan; Sur place; USD 85 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Troubleshooting

Cross-functional comm

Statistical analysis

Documentation

GMP knowledge

Formation

Bachelor’s degree in Engineering

Outils

IQ/OQ/PQ protocols

PPAP

PFMEA

Control Plans

Description du poste

United Pharma is seeking a Process Validation Engineer to support manufacturing process and equipment validation activities for a leading medical device organization in Portage, Michigan. This role focuses on executing IQ/OQ/PQ protocols, analyzing validation data, preparing technical documentation, and troubleshooting manufacturing equipment. The ideal candidate will support product transfers, process improvements, and cross-functional engineering initiatives while ensuring compliance with GMP, quality, and safety requirements.

• Execute equipment and process validation activities, including IQ/OQ/PQ.
• Run manufacturing samples, collect and 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.
• Bachelor’s degree in Engineering or a related field.
• Experience working with manufacturing or test equipment.
• Knowledge of equipment validation and IQ/OQ/PQ.
• Familiarity with PPAP, PFMEA, Control Plans, and statistical analysis preferred.
• Medical device manufacturing experience strongly preferred.
• Strong troubleshooting, documentation, and cross-functional communication skills.