Cleaning Validation Senior Scientist

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在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

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我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

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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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