Process Scientist

hace 5 meses

Madrid, España Kenvue A tiempo completo

**Process scientist**-2307010594W

Description

Kenvue is currently recruiting for:
**Process scientist - Cleaning & Manufacturing/Packaging Process**
This position reports into [Process Science Leader MS&T Self Care Central Europe 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 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.

**What You Will Do**
The cleaning & manufacturing/packaging process scientist leads and executes MS&T process projects and formulation activities
providing technical support for a series of projects associated with the currently marketed OTC products. He/She is responsible
for supporting the Validation Master Plan (VMP) and maintenance of the cleaning & process validated status of each cGMP system
and manufacturing/packaging process within the plant.
The role will also support the introduction and/or transfer of products to the plant.
The products covered include solids, liquids, and topical formulations.
**Key Responsibilities**
Regarding cleaning validation:
Define the validation strategy
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.
Regarding 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 strategy for the assigned projects
Process validation (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
(cGMP) 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 within the validation strategy
Assuring appropriate communication to stakeholders
Audit readiness

**Qualifications**:
**What We Are Looking For**
**Required Qualifications**
7 + 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.
Desired Qualifications
Broad knowledge of pharmaceutical manufacturing and packaging equipment and their process
Well organized, committed, flexible, and really like to work 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 in autonomy while handling multiple priorities.
Regarding cleaning va

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