Process Validation Engineer (IQ/OQ/PQ) – Onsite

iMPact Business Group; Portage (MI); On-site; USD 80,000 - 110,000; Full time

Job summary

iMPact Business Group is seeking a Process Validation Engineer to join our client onsite in Portage, MI on a 12-month+ contract. The role focuses on validating manufacturing processes, collecting data, and documenting results in validation reports to support GMP-compliant production.

You will collaborate with Quality, Operations and Engineering to ensure processes meet requirements, and assist with equipment setup and troubleshooting on the assembly line.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience with manufacturing equipment validation.
• IQ/OQ/PQ validation experience preferred.
• Medical device industry experience is a plus.

Responsibilities

• Run samples on manufacturing equipment, collect and analyze data, and document results in validation reports.
• Collaborate with Quality, Operations and Engineering to ensure processes meet requirements.
• Set up components, fixtures, tooling and equipment on the assembly line; troubleshoot builds.
• Assist and coordinate with materials team to ensure line is ready to receive components/materials.
• Participate in PPAP, PFMEA, Control Plan, and SOP development related to product transfers.

Skills

Equipment Validation

Statistical Methods

Six Sigma / CI

PPAP Experience

GMP Awareness

Education

Bachelor's Degree in Engineering

Tools

IQ/OQ/PQ experience

Validation Reports

Job description

iMPact Business Group is seeking a Process Validation Engineer to join our client onsite in Portage, MI on a 12-month+ contract. The role focuses on validating manufacturing processes, collecting data, and documenting results in validation reports to support GMP-compliant production.

You will collaborate with Quality, Operations and Engineering to ensure processes meet requirements, and assist with equipment setup and troubleshooting on the assembly line.