About this role
Process Validation Engineer (IQ/OQ/PQ)
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
Job Requirements
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
About Portage, MI
Ready to take the next step in your career? Explore exciting job opportunities in and around Portage, Michigan with us today! Nestled in the southwest region of the Great Lakes State, Portage offers a perfect blend of picturesque landscapes, vibrant cultural scene, and abundant career growth opportunities. Imagine working in proximity to Kalamazoo Nature Center, cheering on the Kalamazoo Wings at Wings Event Center, and indulging in the famous Michigan cherry pies. With renowned art galleries like the Kalamazoo Institute of Arts, charming theaters like the Barn Theatre, and the nearby shores of Lake Michigan, Portage invites you to discover a world of possibilities. Let's find your dream job amidst the charm and beauty of Portage, MI!
Contract positions
Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment.
Permanent placed employees
Paid by and qualify for benefits in accordance with the policies of the hiring company.
Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.
Internal Positions
We have several internal positions at iMPact that we are hiring for. Please view our internal positions here.
- Recruiters
- Account Managers
Learn more about working with iMPact Business Group
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iMPact Business Group is a professional staffing agency located in Grand Rapids, MI, and Tampa, FL. We were founded in 2004 and service candidates and clients nationwide. Our areas of specialization are in IT, Engineering, Finance/Accounting, and Business Administration/Process (HR, Marketing, Admin jobs, etc). Opportunities are available nationwide as well as remote.
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