Product and Process Engineer - Maternity Cover

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

Product and Process Engineer – Maternity Cover

About the role

Responsible for development, validation and technology transfer of manufacturing and cleaning processes. Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and stability. Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.

Key responsibilities

Coordinates, plans and executes development and validation of manufacturing processes and equipment cleaning procedures, working across multiple functions to collect the appropriate inputs for validation protocols and authoring validation reports.

Authors documentation required for development / validation trials (protocols / reports, operative instructions, sampling plans, control charts, master formulas, experimental production orders where needed).

Authors Qualitative e Quantitative Composition (QQC) for Dietary Supplement products.

Authors production documentation (working instructions, master formulas, cleaning instructions, SAP Data Collection Forms) for routine manufacturing.

Liaises with Regional and Global Technical, as well as other site functions such as QA, QC, Engineering, and Operations to ensure that proper controls are established and maintained for products to be manufactured in a validated state of control.

Analyzes stability data to support product shelf-life, site programs (e.g. PPRs) and external evaluations (e.g. regulatory notifications and commitments).

Coordinates de-risking and business continuity projects related to raw materials, working closely with suppliers, Quality Supplier, Purchasing, Regulatory Compliance. Implements and maintains continued process verification (CPV), as appropriate, for determined products and processes on site. Incorporates data trending and statistical analysis to verify that processes remain in a validated state of control, and to proactively identify trends which may provide risk to the product.

Maintains and periodically reviews product control strategies (PCS) and technical risk assessments (TRA), as required.

Leads or contributes to, as required, change controls impacting products or manufacturing processes.

Ensures alignment of timelines and activities required for technical changes, product transfers, major deviations, and investigations.

Performs assessments on cleaning processes, as required for new products, processes, or materials introduced to the site, and ensures appropriate validation is implemented. This includes HBEL, MACO, residual solvent calculations, and other assessments to support cleaning validation needs.

Develops and works with Operations to execute protocols for cleaning validation, and issues validation reports.

Updates SOPs regulating the department activities in line with company guidelines and regulations.

Collaborates and supports for technical aspects the other site functions (QA, QC, Regulatory, Procurement, Engineering) for evaluation / preparation of documents such as Change Controls, Master Formulas, deviations, investigations, Risk Assessments, Technical Assessments, Periodic Product Reviews (PPRs),User Requirement Functional Specifications (URFS), HACCP manuals.

Collects and evaluates process data (in process control) and QC analytical data for report preparation.

Collaborates and supports Production for technology issues in commercial productions.

Observes current regulations and company provisions on workplace safety and hygiene and the use of collective protective equipment and personal protective equipment.

Qualifications and skills

BS degree in Chemistry, Engineering, or related area.

2 - 5 years experience in a GxP pharmaceutical regulated environment.

Experience with process validation of pharmaceutical and dietary supplement products of different forms (coated / uncoated tablets, capsules, granules, creams) and packaging technologies (blisters, sachets, sticks, bottles, tubes). Familiarity with microbiological sampling and experience in validation of probiotics products would be a plus.

Experience with cleaning validation of GMP production areas.

Knowledge of statistical softwares (eg. Statistica, Minitab).

Good knowledge of written and spoken English.

Strong relationship management, including the ability to work with inter-functional teams and in a matrix organization with multiple stake-holders interface.

Location: Aprilia

Contract: Maternity Cover

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Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Care to join us. Find out what life at Haleon is really like

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.

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