Senior Specialist Development Engineer (Pharmaceutical)

About the role

A Senior Specialist Development Engineer is needed for the Commercialisation Development and Supply (CDS) team in Ballydine, Co. Tipperary. Reporting to the CDS OSD Commercialisation Technical Lead, you will be a key technical leader in the pharmaceutical CDS group, responsible for final pharmaceutical dosage form process development, transferring processes to production and driving process improvements with R&D and the manufacturing Integrated Process Teams.

Key responsibilities

• Lead the design, scale-up and transfer of new solid oral dosage (OSD) manufacturing processes, including characterization and design space studies, and turn development data into validated commercial processes.
• Lead and take part in cross-functional teams on Quality Risk Assessments, complex quality investigations, safety assessments (HAZOPs) and process improvement initiatives.
• Author, run and lead process and cleaning validation programmes to meet cGMP and global regulatory expectations.
• Provide high-level technical troubleshooting support to the IPT and evaluate raw materials.
• Act as project leader for new product introductions and technology transfers, managing plans, priorities, risks and accountabilities.
• Pioneer and share new techniques, and use Lean Six Sigma tools to improve processes and business systems.
• Ensure compliance with cGMP, environmental and health and safety regulations, and act as Sub-System Owner for Quality Management System areas.

Required profile

• BSc, BEng or higher in Chemical Engineering, Chemistry, Natural Sciences or a related discipline; an advanced degree is beneficial.
• At least 6 years of post-graduation experience in pharmaceutical process development, manufacturing and technology transfer.
• Strong understanding of process chemistry, formulation technology and engineering principles for solid oral dosage forms.
• Excellent written and verbal communication, with the ability to present complex technical data to diverse audiences.
• Ability to lead project teams and work with plant departments such as PCT, process engineering, central engineering and global manufacturing groups.

Required skills

• Process development, scale-up, technology transfer and cleaning validation.
• In-depth knowledge of cGMP, global regulatory expectations and Quality Risk Management.
• Deviation management, root-cause analysis (8-step methodology) and production operations.
• Lean Six Sigma tools.