Senior Manufacturing Process Engineer  Job Listing at Kelly Services in Kalamazoo, MI (Job ID US3569289_BH9851778)

Description

Senior Manufacturing Process Engineer (Product Transfer Validation)  

• Location: Kalamazoo, Michigan (49001)
• Duration: Until 12/31/2025 (contract extension potential)
• Type: W2 contract (NO C2C OR THIRD PARTY)
• Pay: Negotiable depending on direct-related experience
• Work Authorization: Must be currently in the United States with active employment authorization documents.

 

Seeking candidates that have documented 5+ years experience with medical equipment process validations,PPAP, control plans & technical writing.

 

Job Summary:

• This role is within the Product Transfer team.
• 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.

 

What you will do:

• Owns and supports the development of the Validation Plan for highly complex validation projects.
• Owns and supports validation and initial qualification of equipment and systems as related to new equipment for NPI/Product Transfer activities.
• Write, review, and execute studies for process validation, including DOE, OQ, and PQ Analyze equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.
• Coach and mentor others on functionally related topics.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Work with quality engineers to develop component specific testing and inspection protocols.
• Participate in PFMEA, Control Plan, SOP, PPAP and other internal process qualification generation associated with product transfers.
• Ensure adherence to GMP and safety procedures.
• Review and approve of validation documentation.

 

Minimum Qualifications, Knowledge, Skills (Required): Bachelor's degree in an engineering discipline.

• Minimum of 4 or more years' experience in a FDA regulated manufacturing or project environment.
• Experience of process/ product validation.
• Experience with statistical methods, process mapping, root cause analysis.
• Experience coaching and mentoring team members.
• Experience in managing and coordinating projects, workstreams and activities.
• Innovative thinker - should be able to envisage new and better ways of doing things.

 

 

Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.

 

 

 

*** (Kelly does not expense relocation/interview costs)**

 

 

 

• Work Authorization: Must be currently in and able to work in the United States with current employment authorization documents.

 

 

In addition to working with the world's most recognized and trusted name in staffing, Kelly employees can expect:

 

 

 

• Competitive pay
• Paid holidays
• Year-end bonus program
• Recognition and incentive programs
• Access to continuing education via the Kelly Learning Center

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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