Process Science and Validation Specialist

Kenvue is currently recruiting for:

Process Science and Validation Specialist

This position reports into Validation Lead and is based at Cape Town, South Africa.

What we do

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®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who we are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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.

Role reports to: Validation Lead

Location: Cape Town, South Africa

What you will do

Process Science and Validation Specialist 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 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
• Assuring appropriate communication to stakeholders
• Audit readiness

What we are looking for

Required Qualifications

• 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.

Desired Qualifications

• 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:
  • Broad knowledge of cleaning method used for pharmaceutical equipment: manual cleaning, cleaning in place (CIP), semi-automated.
  • Strong skills in cleaning validation and regulatory requirements
  • Capacity to perform criteria calculation regarding the different kind of residues.
  • Strong sensitivity/mindset in cleaning process risk
  • Strong oral and written communication skills.
• 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
• Learning & Development Opportunities
• Kenvuer Impact Networks
• This list could vary based on location/region

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit 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.