Description
Kenvue is currently recruiting for:
This position reports into the Process Science Lead Iberica , Technical Operations, Self Care and is based at Kenvue Ibérica S.L.U plant Manufacturing.

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 by 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.


What You Will Do
The role will also support the introduction and/or transfer of products to the plant. The products covered include solids, liquids, and topical formulations.

Cleaning validation:

• Define validation strategies

• Perform cleaning validation for the introduction of new products to the site or changes to the current product which may potentially impact the cleaning validation status of manufacturing or packaging equipment.

• Establish cleaning assessment for the cleaning process potentially impacted by change.

• Develop the necessary documentation for the realization of the validation runs e.g. cleaning protocols & reports, new recipes and the training of these to production staff involved in the validation activity, if applicable.

• Coordinate with production to ensure that cleaning validation activity is performed.

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

• In the event of non-compliance during cleaning validation, investigate, participate in impact assessment, and propose corrective actions.

• Update cleaning instructions as appropriate.

• Update periodically the relevant sections of the Cleaning Validation Master Plan.

Process validation:

• Driving technology manufacturing process transfer including assessment of the involved risk to the product and alignment with all involved functions on the transfer strategy :

• Define validation and stability strategy for the assigned projects

• Process validation (materials,manufacturing, storage of bulk & packaging) either for the introduction of new products/new materials to the site or changes to the current product e.g. a change of API or excipient/change of primary packaging.

• Creation of protocols and reports to support process validation e.g. characterization and validation activities.

• Collaborate with Production and Quality in the creation of batch documentation required to support process validation e.g. batch manufacturing records.

• Train the relevant production personnel in support of validation activities.

• Follow the production of lots of validation and realize samples.

• Manufacturing process problem resolution and support investigations into deviations during validation activities or routine production, assess and propose corrective actions.

• Update periodically the relevant sections of the Validation Master Plan.

• Follow rules of conformity defined by the guide of the good manufacturing practices of the pharmaceutical industry (c GMP) as well as the guidelines and procedures (Quality and Compliance) defined on the plant.

• Ensuring adequate documentation is available to support registration of projects

• Assuring appropriate risk management

• Assuring appropriate communication to stakeholders

• Audit readiness

Qualifications
What We Are Looking For
5 + years of experience in process and drug product development, drug product manufacturing or related area within the pharmaceutical industry and technical knowledge is essential. Experience in cleaning validation is also required.

• Broad knowledge of pharmaceutical formulation, manufacturing and packaging systems and process

• Well organized, committed, flexible, and enjoy working on the shop floor.

• Capacity to influence others without direct line authority.

• Strong leadership skills and team spirit to collaborate with varied people at different levels

• Capacity to work autonomously while handling multiple priorities.

• Strong statistical knowledge

• Strong presentation skills

• Cleaning validation:

• As we are working in an international organization, good verbal and written English is a prerequisite.

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 identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Spain-Community of Madrid-Madrid

Job Function R&D