Validation & Hygiene Standard Engineer

Job Description

The Validation & Hygiene Standard Engineer will fully support the PPIT Team and Quality Department at the Flint Mill, Wet Wipes facility.

The role supports the PPIT and Quality function to ensure cosmetic regulations, OGSiM KPI’s, WWTF and QMS requirements are met or exceeded.

PRINCIPAL ACCOUNTABILITIES:

• Carry out all job responsibilities in a safe manner. Develop and deliver equipment and processes that meet safety requirements, policies, and guidelines. Provide for the safety and well-being of operators, maintenance, and other personnel.

• Observe all applicable quality procedures and regulations. Perform tasks utilizing Good Manufacturing Practices. Improve process capability to deliver a reduction in defects and variability. Identify, develop, and implement products, processes, materials, systems, and procedures to achieve business objectives in a cosmetic-regulated facility.

• Develop, execute, and review validation protocols (IQ, OQ, PQ and CSV), specification requirement documents, test plans, project plans and procedures. Responsibilities can include computer validation for manufacturing and related automation systems, formulation and solution validations, and validation of packaging and manufacturing processes and equipment.

• Lead validation activities to support projects and ongoing mill operation, including maintaining the Site Master Validation Plan

• Establish the overall qualification/ validation requirements and strategies for new and modified processes related to material changes, process / product changes, and equipment changes or upgrades through the use of risk-based methods. Where applicable, Partner with cross functional teams to use LEAN problem-solving techniques to identify root cause and mitigations of process issues as they arise during operation. incorporate tools such as Design of Experiments and Lean Six Sigma concepts to solve product /process nonconformance issues.

• Train and develop others within the area of the incumbent’s expertise.

• Support the Quality function to drive continuous improvement to meet the Global Quality, Sanitary Manufacture standard for the manufacture of wet wipes.

QUALIFICATIONS:

• Ideally a bachelor’s degree in Engineering, Life science or related discipline with a minimum of 3 years of process validation experience in a cosmetic or medical device regulated manufacturing site.

• Experience developing, leading, and executing various validations in a regulated environment.

• Experience and familiarity with Quality Management System requirements for consumer products and applicable regulatory requirements for cosmetics, including knowledge of ISO 22716.

• Demonstrated knowledge of GMP regulations and good documentation practices is required.

• Practical knowledge on risk management processes (e.g. HACCP, FMEA, etc.), statistical data analysis, and change control.

• Strong verbal and written communication skills.

• A demonstrated ability to perform in cross-functional teams to achieve objectives within required time frames.

• Experience with Lean Manufacturing principles, structured problem-solving methodologies (Lean, Six Sigma, etc.) and process control.

• 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.

• Kimberly-Clark is an 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.

• K-C requires that an employee have authorisation 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.

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