R&E Sr Process Validation Leader at Kimberly-Clark Corporation in neenah, Wisconsin

Job Description:

R&E Sr Process Validation Leader

Job Description

JOB SUMMARY:

The primary purpose of this position is to provide Process Validation leadership for Family Care (FC) North America with an initial focus on Flushable Wipes. The position will work close with K-C’s process validation experts applying advanced knowledge and principles to R&E and manufacturing processes that directly impact business operations. S/he will be responsible for providing strategic and tactical vision that align process validation capabilities with innovation needs for all FC products. The incumbent must support the definition and development of procedures and standards with validation technical leadership and then drive the process validation strategies across the different FC teams for installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). This position is instrumental in ensuring FC meets FDA regulatory requirements for best in class products being delivered to customers and consumers.

ORGANIZATION:

• Reports to: SR. R&E Manger




• Direct reports: No direct reports; however, will indirectly provide work direction and technical mentorship to senior-level technical professionals at the various mill sites across North America with a focus on high risk sites.




• Collaboration / Customers: Supply Chain, Manufacturing, Quality, Regulation, IT, and Research and Engineering for Family Care.




• This role will need to operate with a high level of independence leading and managing critical initiatives across multiple functional areas, business units and manufacturing sites across FC North America.




• R&E budget: $500M - $5MM



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  Capital budget: $1MM - $10MM

  
  
  
  

RESPONSIBILITIES:

• A primary accountability will be to define, deploy and lead Process Validation governance, practices and processes across FC products.




• Lead and execute the development of validation guidelines, protocol, documentation, and training across Family Care working close with Personal Care Technical Leadership as the owners of the KCNA Process Validation Procedures.




• Work with FC Technical Leaders, Managers, 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 FC business unit’s results.




• Attend and support the KCNA Process Validation Review Board comprised of representation from Quality, R&E, and Manufacturing.




• 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.

The FC Process Validation Leader should have a strong background in FC engineering, processes, and materials (especially toward the higher risk products) and/or strong Process Validation expertise.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Contribute to performance management and career development responsibilities for the broader R&E organization.




• Implement documentation and reports as required by R&E; effective communication, protection of proprietary information, and compliance with applicable laws and regulations.

MINIMUM REQUIREMENTS:

• Education required/ preferred: This position requires a bachelor’s 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.




• 10+ years of experience in technical, scientific, or engineering roles.




• 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.

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 and the ability to work independently with minimal direction.




• Great written and verbal communication skills, including ability to communicate clearly, concisely and effectively.

Travel: Ability to travel by ground and air as necessary up to 25% of the time to include some international travel.

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark. 

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.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

This position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job.

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. This position is subject to drug and alcohol testing, including pre-employment testing.

Global VISA and Relocation Specifications:

K-C will support in country relocation for the chosen candidate for the role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will be decided in K-C’s sole discretion.

Primary Location

USA-WI-Neenah

Additional Locations

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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