Role Description: API Process Engineer

The API Process Engineer is responsible for providing technical support for production activities in various API facilities on-site. This role involves working on multiple projects, including manufacturing support, late-stage clinical product development, scale-up, new product introductions, and technology transfers. The API Process Engineer plays a key role in new product introductions and technical transfers, evaluating raw materials, optimizing and developing chemical API processes, ensuring compliance with safety and environmental regulations, monitoring processes, investigating and resolving deviations, and developing filing strategies.

Key Responsibilities

• Guiding the site on new product introductions and technical transfers, including the implementation of new technologies.
• Evaluating raw materials and developing process fits for API production.
• Optimizing and developing chemical API processes.
• Participating in campaign preparation, safety and environmental reviews, and batch sheet reviews.
• Ensuring regulatory and validation compliance.
• Monitoring process performance and addressing any deviations.
• Developing filing strategies for API processes.
• Collaborating with a diverse, multi-functional team to deliver results within schedule and product launch milestones.
• Working closely with Research and Development partners globally.
• Solving technical issues and applying problem-solving skills to achieve positive outcomes.
• Identifying scale-up opportunities and overcoming constraints and challenges during piloting and validation processes.

Experience, Knowledge & Skills

• Experience in process modeling/simulation and/or data analytics is advantageous.
• Demonstrated ability to be self-motivated and inspire others in implementing improvement initiatives.
• Effective planning, prioritization, and time management skills.
• Ability to meet deadlines and deliver quality results.
• High personal integrity, credibility, and energy.
• Experience working as part of diverse teams.

Qualifications & Education

• B.S. or M.S. degree in Chemical Engineering, Pharmaceutical Sciences, or a related engineering/scientific discipline.
• Experience in API production or a related environment is advantageous.

If you are interested in this opportunity and meet the requirements, please contact Eoghan Colton on 086 839 5533 or stem@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ 

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.