Job Description
An amazing opportunity has arisen for an Associate Specialist, Engineering. This is an exciting and challenging opportunity to work on multiple Drug Product projects, contributing to product development and scale-up, new product introductions and technology transfers, as well as manufacturing support activities.
This position is for an Engineer in the Commercialisation, Development and Supply (CDS) group. This group is responsible for process development of Active Pharmaceutical Ingredients (API), Oral Solid Dose (OSD) and potent products from Phase IIb through regulatory filings, process validation, and into the first few years of commercial launch. The group is part of the Global Pharmaceutical and Commercialization (GPC) organization and collaborates with colleagues across the globe on developing new products.
First established in 1976, our Ballydine facility develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. Ballydine was our Company’s first site in Ireland, the Ballydine site is our Company’s primary small molecule pipeline commercialisation facility globally, operating as a European hub for quality, manufacturing, and engineering. Its highly skilled teams lead the way in the development of new medicines, including innovative treatments for Hepatitis C, HIV and immuno‑oncology, the site exports to over 25 countries around the world.
Responsibilities
Plan, conduct, evaluate and interpret process development studies, including scale‑up, OSD/Spray drying characterization, and design space development.
Clinical and formal stability batch manufacture.
Leading and participating in cross‑functional teams to carry out Quality Risk Assessments, Quality Investigations, and Safety Assessments.
Process validation.
Problem‑solving skills are essential and knowledge of concepts of Quality by Design, including risk‑based approaches to development, design of experiments, and process modelling, are desired.
Support commercial supply activities – including process and cleaning recipe and documentation preparations.
Technical support to production and cleaning campaigns.
Troubleshooting investigations and documenting process issues and deviations.
Identifying and implementing process improvement and optimization opportunities.
Other responsibilities include data analysis, technology evaluation, and compliance with applicable safety and current good manufacturing practices.
What Skills You Will Need
Minimum of 1–3 years relevant experience in Oral Solid Dosage or Spray Drying.
Strong oral communication skills.
Proficiency in technical writing.
Work independently and deliver work tasks on time.
Bachelors or postgraduate degree in Chemical or Process Engineering or a Science related discipline.
Required Skills
Chemical Engineering, Data Analysis, Engineering Design, Engineering Standards, Estimation and Planning, Industrial Engineering, Manufacturing Equipment, Manufacturing Scale‑Up, Problem Solving, Process Improvements, Professional Engineering, Project Management, Self‑Motivation, Teamwork, Technical Writing.
Preferred Skills
None
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office‑based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application.
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