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Senior Process Validation Leader

Company: Kimberly-Clark
Location: Beech Island
Posted on: November 22, 2021

Job Description:

Senior Process Validation Leader **Job Description** * You are an engaging communicator * It takes clarity of mind to communicate as well as you do. You realize that people think and process information differently, and so you make sure that you understand your audience and establish a rapport. Then, you craft your message to resonate with their mindset and needs. You ask good questions, knowing that people do not always clearly express what they mean. Please connect with us! * Unity is strength. Experience a truly supportive workplace! * Commitment to a group effort powers our organization. It creates strong relationships among co-workers and empowers each of us to see our particular strengths as one facet of the well-rounded work community. Its a powerful arrangement that helps move careers forward. We foster a culture that seeks to empower people of all diverse personal backgrounds by providing a welcoming, inclusive workplace where opportunities are open to all. Join us. *Primary Responsibilities:* * A primary accountability will be to define, deploy and lead Process Validation governance, practices and processes across Wet Wipes products and processes * Lead and execute the development of validation guidelines, protocol, documentation, and training in Wet Wipes working close with the Family Care Quality and Engineering Team Leadership to align on the KCNA Process Validation Procedures. * Work with Wet Wipes Operations and Engineering teams, capital leads, vendors and manufacturing to identify, write and execute protocols with documentation for the validation of new and existing processes; including but not limited to product, materials and process migrations. * Develop master validation plans to identify processes to be validated, the schedule for validations, interrelationships between processes requiring validation and timing for revalidations. * Ensures compliance to process validation protocol are followed in the design of experiments for projects, products and existing processes that have a direct impact on the Wet wipes business results. * Attend and support the KCNA Process Validation Review Board comprised of representation from Quality, R&E, Manufacturing, and Regulatory Affairs. * Identifies requirements and strategy to ensure the validated state is maintained. * Maintain accurate tracking of validation studies, equipment, and facility status. * Regularly reviews and monitors trends within the product development and design processes to ensure the process remains within the established parameters. Investigations when a negative trend occurs and leads the appropriate corrective action (CAPA & QNC). * Ensures activities and items are in compliant with both company quality assurance standards and applicable government regulations, such as GMPs and FDA Cosmetic requirements. * Contribute to building process validation capability and awareness within the broader Wet Wipes team2. Implement documentation and reports as required by the Wet Wipes business, effective communication, protection of proprietary information, and compliance with applicable laws and regulations. * Implement documentation and reports as required by the Wet Wipes business, effective communication, protection of proprietary information, and compliance with applicable laws and regulations. * Minimum Requirements: * * Bachelors degree in Engineering or comparable degree associated with Process Validation * Preference for deep understanding of Family Care products, processes, and materials * Preference for a Black Belt in Six Sigma and working knowledge and experience in process validation statistical software * Experience: * * 10+ years of experience in technical, scientific, or engineering roles * 3+ years of experience in Process Validation3. Preferred experience in FDA Cosmetics regulated products * Critical Skills/Qualifications: * * Strong process development and optimization skills, with experience in experimental design * Demonstrated ability to conceive, develop and validate ideas leading to new or improved products, processes, materials and systems * Ability to lead and facilitate problem solving across teams to achieve desired results. * Technical understanding of high speed manufacturing systems, materials, product and competitive process knowledge. * Demonstration to be disciplined in approach with the ability to adhere to documented processes and ability to hold others accountable to standard processes * Important Skills/Competencies: * * Ability to network, collaborate and influence across staff functions and departments as well as manufacturing sites * Ability to effectively influence across all levels of the organization * High level of personal and professional integrity and trustworthiness with a strong work ethic andthe ability to work independently with minimal direction * Great written and verbal communication skills, including ability to communicate clearly, concisely and effectively. *Working Conditions:* * Ability to effectively communicate to individuals and groups. * Ability to work under normal office conditions. * Ability to travel by ground and air as necessary up to 25% of the time. * Were a community in which everyone feels free to participate * In our dynamic, collaborative organization, our inclusive environment encourages every member of our diverse staff to feel comfortable speaking out and sharing ideas. There are no glass ceilings - no limits to opportunities for anyone willing to share their skills and add their unique perspectives. In our respectful, appreciative workspace, even those who do not often speak out find their voice. 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 worlds 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. 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. *Global VISA and Relocation Specifications:* **Primary Location** USA-SC-Beech Island **Additional Locations** **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time

Keywords: Kimberly-Clark, Augusta , Senior Process Validation Leader, Other , Beech Island, Georgia

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