Process Science and Validation Specialist

Description

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 cleaning & manufacturing/packaging process scientist leads and executes Technical Operations 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 powder formulations.

Key Responsibilities

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 prima...