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Senior api process engineering specialist

Dublin
beBeeChemicalEngineering
Process engineer
Posted: 13 December
Offer description

Job Description

We are seeking an experienced Process Engineering Expert to join our team. The successful candidate will be responsible for designing, scaling, and controlling API processes from clinical development through commercial supply.

The role involves applying chemical engineering and process chemistry fundamentals to deepen process understanding, strengthen control strategies, and support regulatory submissions for global markets.

As a Process Engineering Expert, you will become the central hub for API process knowledge, driving best practices and continuous improvement across our manufacturing network and external partners.

* Lead the Small Molecules API Manufacturing Sciences activities within Global Process Science.
* Provide process engineering support for batch and continuous API platforms from clinical through commercial stages.
* Apply mechanistic modelling, process simulation, and quantitative analysis to enhance process understanding and enable robust process control.
* Lead API manufacturing process characterization, including risk assessments and definition of critical process parameters and controls.
* Lead technology transfer of API processes between internal sites and external partners, ensuring robust, reproducible, and compliant implementation.
* Lead API process validation activities, including strategy, protocol design, execution support, and data evaluation.


Required Skills and Qualifications

To be successful in this role, you will need:

* A Master's degree in Chemical Engineering, Process Engineering, or Pharmaceutical Engineering.
* No less than 5 years of experience in a cGMP manufacturing environment and at least 5 years of pharmaceutical industry experience in small-molecule APIs.
* Strong foundation in organic/pharmaceutical chemistry and chemical engineering, with applied experience in API manufacturing processes.
* In-depth understanding of pharmaceutical manufacturing processes, ICH guidelines, and current global regulatory requirements relevant to API processes.
* Demonstrated experience in mechanistic modelling, process simulation, and data-driven process optimization.
* Proven track record leading API process characterization, technology transfer, process validation, and lifecycle changes in a multi-site or global context.


Benefits

At our company, we offer a stimulating work environment that fosters innovation and excellence. We are committed to creating a diverse workforce and provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

We strive to empower our people to shine and deliver better health and a brighter future to people around the world.


Location

This position is available globally, with travel opportunities to international manufacturing sites.


What You Bring to Our Company

We value candidates who bring intellectual curiosity about technology and new ways of working, coupled with a collaborative and open mindset.

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