Process Validation Engineer (IQ/OQ/PQ) - 27718

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

Process Validation Engineer - Onsite Portage MI

12-Month+ Contract | 1st Shift | M-F 8:00am-5pm . 40hr scheduled with occ overtime.

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Process Validation Engineer for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

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 Stryker internal process qualification generation associated with product transfers.

Position Description and Responsibilities

• 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

Qualifications:

• Bachelor's Degree in Engineering or relevant field of study.
• Experience working with manufacturing equipment.
• Validation experience highly preferred - Equipment validation, IQ/OQ/PQ experience
• Technical Aptitude preferred.
• Medical Device Experience highly desired