Cleaning Validation Senior Scientist

Cleaning Validation Senior Scientist

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

EMEA Tech Ops Head

Lieu :

Europe/Middle East/Africa, Sweden, Skane, Helsingborg

Lieu de travail :

Entièrement sur place

Ce que tu vas faire

Kenvue is currently recruiting for a:

CLEANING VALIDATION SENIOR SCIENTIST

This position reports into the Smoking Cessation Process Science Leader and is based at Kenvue Helsingborg 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 cleaning validation senior scientist is responsible for supporting the Validation Master Plan (VMP) and maintenance of the cleaning validated state of manufacturing and packaging equipment within the plant.

Key Responsibilities
• Define cleaning 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 cleaning validation matters.
• Perform cleaning validation activities for the introduction of new products to the site or changes to the existing product
• Document cleaning assessment for cleaning processes potentially impacted by change.
• Define and document equipment mapping to identify sample points.
• Lead realization of 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.
• Coordinate with production to ensure that cleaning validation activity is performed within suitable timelines as defined within project plans or the site VMP.
• May also support the execution of analytical analysis in the QC laboratory .
• Oversee cleaning validation runs and coordinate the sampling.
• Prepare the relevant validation report for approval.
• In the event of non-compliance during cleaning validation, investigate, participate in impact assessment, and propose corrective actions.
• Identify the potential cleaning optimization and improvement opportunities
• Update cleaning instructions, VMPs and the related matrixes, as appropriate.
• Contribute to Audit 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.
• 7 + years of experience in cleaning validation is required or production or quality in Pharmaceutical, Medical Device Manufacturing and OTC Drug
• 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 English is required

Desired Qualifications
• Broad knowledge of pharmaceutical/OTC 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 & 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.

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