Job Description
An amazing opportunity has arisen for an Engineering Specialist.
This is an exciting and challenging opportunity to work on Spray Drying projects, contributing to product development and scale-up, new product introductions, technology transfers, and providing technical support to commercial manufacturing 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), Spray Dried Intermediate (SDI), and Oral Solid Drug (OSD) 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.
What you will do: Bring energy, knowledge, innovation, and direction to carry out the following:
Plan, conduct, evaluate, and interpret process development studies, including scale-up, Spray drying characterization, and Design space development.Provide technical support for executing clinical and primary stability batch manufacture.Lead and participate in cross-functional teams to carry out Quality Risk Assessments, Quality Investigations, Safety Assessments, and Process improvement projects.Prepare, lead, and execute Process and Cleaning Validation activities.Support commercial supply activities such asProcess and cleaning recipe and manufacturing documentation preparations/approvals.Technical support to process and cleaning campaigns.Troubleshoot, lead/completing investigations, proposing/implementing Corrective and Preventative Actions.Identify and implement process improvement and optimization opportunities for both production and cleaning regimes.Other responsibilities include data analysis, technology evaluation, and compliance with applicable safety and current good manufacturing practices.What skills you will need: In order to excel in this role, you will more than likely have:
Ideally 3-5 years of relevant experience in a Pharma Environment.Strong oral communication skills.Proficiency in technical writing.Essential problem-solving skills and knowledge of concepts of Quality by Design, including risk-based approaches to development, design of experiments, and process modelling.Ability and willingness to occasionally support shift work depending on the needs of the project or team.Ability to learn quickly and work in a fast-paced team environment.Ability to work independently and as part of a team while meeting all agreed timelines.Bachelor's or postgraduate degree in Chemical or Process Engineering or a Science-related discipline.
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