Validation Specialist

Validation Specialist

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

MS and T Self Care Central European Process Science Leader

Location:

Europe/Middle East/Africa, France, Normandy, Val-de-Reuil

Work Location:

Fully Onsite

What you will do

Kenvue is currently recruiting for:

VALIDATION SCIENTIST

This position reports into Process Science Leader and is based at Kenvue/ JNTL Val-de-Reuil manufacturing plant.

Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

What You Will Do

The validation specialist is responsible for supporting the Validation Master Plan (VMP) and maintenance of the manufacturing and cleaning validated state of equipment within the plant.

Key Responsibilities

· Define validation strategies considering scientific/technical data, risk assessments and applicable quality and regulatory requirements. Serve as subject matter expert to identify optimization and improvement opportunities in validation matters.

· Identify potential optimization and improvement opportunities, and drive continuous improvement initiatives at site to enhance production efficiency and strategically reduce complexity.

· Act as technical expert in root cause analysis and trouble shooting, coordinate technical issue resolution with cross functional team.

· Perform validation activities for the introduction of new products to the site or changes to the existing product, encompassing:

o Document cleaning assessment for cleaning processes potentially impacted by changes.

o Define and document equipment mapping to identify sample points.

o Conduct cleaning validation activities and issuance of all related documentation e.g. issue cleaning validation protocols, new/updated cleaning recipes, conduct training of production staff involved in the validation activities, if applicable.

o Coordinate with production to ensure that validation activity is performed within suitable timelines as defined within project plans or the site VMP.

o Coordinate with QC for the analysis of samples and reporting of results.

o Oversee validation runs and perform the sampling.

o issue or approve validation reports.

o Update cleaning & process instructions, VMPs and the related matrixes, as appropriate.

· Contribute to inspection readiness activities on site and act as Subject Matter Expert (SME) in audits and inspections received by the site, including preparations in back room and auditor/inspector facing in front room.

What We Are Looking For

Required Qualifications

· At minimum a master’s degree in a scientific field is required.

· 5 + years of experience in cleaning validation is required or production or quality in Pharmaceutical, Medical Device Manufacturing, OTC Drug and/or Cosmetic production.

· Working knowledge of cGMP requirements (e.g. Eudralex Vol4, FDA CFR21 parts 210 211, …)

· Proficiency in MS Word, Excel, and Power Point applications is required.

· Strong leadership skills and team player, to effectively collaborate with a variety of functions and different seniority levels

· Fluency in French and English are required

·

Desired Qualifications

· Broad knowledge of pharmaceutical/cosmetic equipment and related cleaning methods: manual cleaning, cleaning in place (CIP), semi-automated cleaning.

· Capacity to perform criteria calculation for the different kinds of residue.

· Well organized, autonomous, committed, flexible, and really like to work on the shop floor.

· Capacity to work in autonomy while handling multiple priorities.

· Experience in applying risk management tools and ability to clearly articulate/communicate risks.

· Strong verbal and written communication skills.

What’s In It For You

· Competitive Benefit Package

· Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

· Learning & Development Opportunities

· Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.