Senior Test Method Validation Engineer

Company: Kimberly-Clark
Location: Neenah
Posted on: June 24, 2022

Job Description:

You're looking to make a difference. When and where it works best for you. And at Kimberly-Clark, we're constantly exploring new ideas on how, when and where we can best achieve results. When you join our team, you'll experience Flex That Works, flexible work (hybrid) arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business.This position plays a critical role in the development of KCNA consumer products and works in conjunction with the broader R&E and Quality teams to develop our design, verification and validation strategies, and design controls. This individual is accountable for test method validation requirements across KCNA consumer products and medical devices including Poise, Depend, U by Kotex, Huggies, Kleenex, etc. for testing occurring in our Wisconsin based physical testing laboratories. The individual will often work in group settings but also needs to be able to work autonomously and disseminate direction throughout the KCNA organization.We are seeking a highly motivated, detail-oriented Test Method Validation- Senior Engineer in support of the KCNA Product and Consumer Science Organization. This individual will be responsible for developing a test method validation plan across the physical testing laboratories closely working with the broader R&D and Quality teams. The role reports to a Senior R&E Manager, takes work direction from a Research Technical Leader, and is located in Neenah, WI.RESPONSIBILITIES

• Compile and analyze verification and validation data, prepare documentation, and make recommendations for changes and/or improvements
• Coordinate and guide across functions: R&E, regulatory, quality, marketing, product supply, safety, etc.
• Lead programs as needed with -10% travel. Majority of travel will be to North American laboratory and/or manufacturing locations.
• Team member may have several other team members taking work direction and guidance on TMV implementation, including contractors.
• Team member will maintain the TMV pipeline across all test methods. Define prioritization of work for TMV. Ensure quality and regulatory compliance with our standards and in compliance with FDA and Health Canada regulations.BASIC QUALIFICATIONS
  • Candidates must possess a bachelor's or advanced degree in an Engineering or Scientific discipline from an accredited College or University.
  • 4 -7+ years of experience in product development, process development, validation engineering and/or medical device development.
  • Experience in development and execution of test method validation.
  • Knowledge of medical device Design controls, Design Development, and associated Design Governance.
  • Experience with ETQ or related systems and documenting in a regulated environment.
  • Demonstrated leadership skills providing work direction to a multi-functional team including internal and external resources.
  • Proven track record of ability to resolve complex problems.
  • The ability to work well with other groups in a collaborative environment.
  • Excellent written and oral communication skills.PREFERRED QUALIFICATIONS
    • Product knowledge of consumer products such diapers, tissue, wet wipes, tampons and/or pads.
    • Additional experiences within Process Validation, Risk Management, and Quality systems.
    • Experience in managing details in an FDA regulated environment and knowledge of FDA 21 CFR 820.30 and ISO13485 standards.
    • Knowledge of statistical methods, CAPA, and high-speed manufacturing.
    • Experience representing an organization with FDA and related audits.No more struggle or guesswork. Our mentorship program will guide your success!Our organization offers you a guided pathway that could make this position the most valuable move in your career. Your mentor, an experienced colleague, will help you to strengthen areas that could be stronger and develop strategies and tools to master work-related issues. We welcome, respect and include people from diverse backgrounds, and gratefully acknowledge that while we help you to grow, the perspectives and skills you contribute will help us.Kimberly-Clark makes the essentials for a better life with well-known brands that matter every day - at home, school, work and on the go. Throughout our 148 years, we have challenged conventional wisdom to innovate products that better meet the needs of consumers. We have created new categories with top brands like Kleenex -, and redefined categories with Huggies - and U by Kotex -. While growing our $18+ billion global business, we help build careers through collaborative teams that push boundaries and endless opportunities to work with some of the world's most recognized brands. Our 43,000 employees are changing the world for the better, too, generously giving back to communities and causes around the globe. For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law. With an inclusive culture, our employees - and the original thinking they bring to Kimberly-Clark - make us stronger. EOE disability/vet.Global VISA and Relocation Specifications:K-C requires that an employee have authorization to work in the country in which the role is based. In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on immigration requirements, not all roles are suitable for sponsorship.

Keywords: Kimberly-Clark, Green Bay , Senior Test Method Validation Engineer, Engineering , Neenah, Wisconsin