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CYTIVA US LLC

Product Engineer II

Career Insights for Validation Engineer

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What they do

A Validation Engineer evaluates and maintains machinery and equipment used in manufacturing, and supervises workers that use and repair the machines.

$98,284 / year median in Florida

+2% projected growth

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Job Description

Job Description Help for Job Description. Opens a new window. Product Engineer II is responsible for lead and support projects to resolve customer and manufacturing issues using data driven structure problem solving methodologies. Work cross-functionally with R D and other teams to support new product introduction (NPI, validation and qualification activities. This position reports to the Sr. Product Engineering Manager and is part of the Product Engineering Team located in Pensacola, Florida and will be an on-site role.
What will you do:
To ensure a safe work environment while meeting the physical demands of the job, you must be able to perform the following physical and mental tasks, with or without a reasonable accommodation: Lead and execute structured problem-solving (DMS, PSP, A3, 5 Whys) to resolve customer complaints, nonconformances, and manufacturing deviations, ensuring timely containment, root cause identification, and sustainable countermeasures. Partner with R D, Quality, and Manufacturing to support New Product Introduction (NPI) through design transfer, process characterization, validation (IQ/OQ/PQ), and readiness reviews. Own or support raw material change management, including impact assessments, supplier change evaluations, risk analysis, and execution of validation/verification plans to ensure compliance and product performance. Analyze process and quality data using DBS tools to monitor capability, identify trends, and drive continuous improvement in yield, cycle time, and product robustness. Drive and support change control processes (ECR/ECO) ensuring proper documentation, risk mitigation, and cross-functional alignment in a regulated environment.
Who you are:
Bachelor of Science (BS) in Engineering or related technical field. 3+ years of experience in product engineering, process engineering, quality engineering, or product development in a regulated manufacturing environment. Working knowledge of manufacturing processes, preferably in polymeric materials (membranes, films, nonwovens), with ability to apply that knowledge to solve problems and improve processes. Familiarity with change control processes (e.g., ECO/ECR) and raw material change management, including risk assessments and documentation in a regulated (cGMP/ISO) environment. Strong analytical, communication, and organizational skills. It would be a plus if you also possess previous experience in: New Product Introduction (NPI), including validation (IQ/OQ/PQ) and design transfer activities. Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Employer is an affirmative action/equal opportunity employer. All Qualified applicants will receive consideration for employment without regard for race, religion, color, national origin, sex, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.