- A fantastic opportunity has arisen for an API Process Engineer to join our client’s busy biopharmaceutical facility in Co. Tipperary.
- The successful candidate will provide technical support for production across various API facilities on site.
- These are exciting and challenging opportunities to work on multiple projects, ranging from manufacturing support activities to late-stage clinical product development and scale-up, new product introductions and technology transfers.
Core Duties and Responsibilities:
- A key contributor and guiding the site on a new product introduction or technical transfer to and from the site, including new technologies.
- The role involves evaluation of raw materials, development of process fits, optimisation and development of the chemical API process, participation in campaign preparation, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring, deviation investigations and resolution, and developing filing strategies.
- You will work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones, this may involve directing day to day will development plans across projects and working closely with Research and Development partners globally.
- The successful candidate will have an aptitude for technical problem solving, with a background in solving technical issues to obtain a positive outcome.
- Knowledge and subject matter expertise on API processing unit operations and scale up opportunities are a core part of the role, with the ability to identify and overcome constraints and tests to ensure successful demonstration of processes through piloting and validation.
Education & Qualifications Required:
- S. or M.S. degree in Chemical Engineering, Pharmaceutical Sciences, or related engineering/ scientific discipline.
- Experience in API production or related environment is an advantage.
- Experience in process modelling/simulation and/or data analytics would be an advantage.
- Demonstrated ability to be self-motivated and focus others with respect to implementing identified improvement initiatives.
- Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
- High personal integrity, credibility and energy.
- Demonstrated ability to work as part of diverse teams.
Please note, we do not require agency assistance with this role.