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Plexus • Neenah, Wisconsin, United States
Salary: $85,100 - $127,700 / year
Role & seniority: Senior Validation Engineer (7+ years of related experience; Bachelor’s degree preferred)
Stack/tools: Validation protocols and master plans; documentation packages; standard operating procedures; regulatory guidelines (FDA/other); project scheduling; cross-functional coordination
Develop and execute validation protocols and documentation for equipment and processes
Create validation master plans and ensure adherence to schedules and protocols
Maintain up-to-date knowledge of validation requirements, prepare reports, and assist Program Manager with resource planning
Bachelor’s degree and 7+ years’ related experience (or equivalent)
Deep knowledge of validation processes, protocols, SOPs, and regulatory practices (FDA)
Ability to prepare documentation, schedules, and management reports; strong coordination across teams
Experience in aerospace/defense, healthcare/life sciences, or medical device environments
Prior experience with validation master plan creation and more complex program management
Regulatory affairs exposure or advanced degree
Location & work type: Full-time role; location not specified; travel requirement 10% or less; global collaboration environment (benefits referenced).
About us: At Plexus, our vision is to help create the products that build a better world. Driven by a passion for excellence, we partner with leading Aerospace/Defense, Healthcare/Life Sciences and Industrial companies to design, manufacture and service some of the world’s most transformative products, including advanced surgical systems, diagnostic instruments, healthcare imaging equipment, mission critical aerospace systems, and electric vehicle (EV) charging solutions. Visit Plexus.com to learn more about our unwavering commitment to our vision. When we invest in our people, we invest in building a better world. With a vision rooted in the wellbeing and inclusive engagement of our team members, our customers, their end users and our communities, people are the heart of what we do and who we are. It is our values that unite us and guide us in everything that we do, including how we operate, behave and interact to foster a workplace where every team member feels valued and empowered to contribute their best. Our values include: Growing our People, Building Belonging, Innovating Responsibly, Delivering Excellence and Creating Customer Success. As a team member, you will engage in impactful work through global collaboration and the use of emerging technologies, join an inclusive culture where every team member is valued and working toward a greater purpose, and be empowered to reach your full potential through various development programs designed to accelerate your growth. Plexus offers a comprehensive benefits package designed to support team members' wellbeing, including medical, dental, and vision insurance, paid time off, retirement savings, and opportunities for professional development. We also prioritize work-life balance and offer a variety of perks to enhance the team member experience. For more information, visit our US benefits website at usbenefits.plexus.com. Our commitment to pay range transparency fosters an equitable workplace, where everyone can feel valued. The annual compensation range for this position is stated below. The salary offered within this range will be based upon the geographic location, work experience, education, licensure requirements and/or skill level. Salary Range: $85,100.00 - $127,700.00 Purpose Statement: This role is responsible for the proper qualification and validation of equipment and processes in accordance with FDA or other regulatory guidelines. Key Job Accountabilities: Develops and executes various validation protocols and documentation packages for all required equipment and processes. Develops validation master plans and protocols for various projects. Have a working knowledge, and remain up-to-date on all validation requirements, practices, procedures and industry trends for validation process and development. Prepares and maintains project schedules and implement protocols for validation. Assists Program Manager in all validation plans for projects and determine all resources required for validation. Education/Experience Qualifications: Bachelor’s Degree with 7 or more years of related experience is preferred. An equivalent combination of education and/or experience will be considered. Other Qualifications: Prepares and implements all validation processes according to standard operating procedures. Coordinates with various validation work tasks and prepare reports to submit to management. Collaborates with the validation team for protocol creation, execution and schedule adherence. Travel Requirements: 10% or less This document does not represent a contract of employment and is not intended to capture every possible assignment the incumbent could be asked to perform. We are pleased to provide reasonable accommodations to individuals with disabilities or special requirements. If you need an application accommodation, please contact us by email at . Please include your contact information and clearly describe how we can help you. This email is for accommodation requests only and cannot be used to inquire about the status of applications. We are an Equal Opportunity Employer (EOE) and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Some offers of employment are contingent upon successfully passing a drug screen and/or background check. Since 1979, Plexus has been partnering with companies to create the products that build a better world. We are a team of over 20,000 individuals who are dedicated to providing Design and Development, Supply Chain Solutions, New Product Introduction, Manufacturing and Sustainability Services. Plexus is a global leader that specializes in serving customers in industries with highly complex products and demanding regulatory environments. Plexus delivers customer service excellence to leading companies by providing innovative, comprehensive solutions throughout a product’s lifecycle. For more information about Plexus, visit our website at .