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 experienceWork 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 .*** (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 payPaid holidaysYear-end bonus programRecognition and incentive programsAccess to continuing education via the Kelly Learning Center