Job Description

An amazing opportunity has arisen for a Development Engineer to join our Commercialisation Development and Supply (CDS) team in Ballydine, Co. Tipperary.

Reporting to the CDS OSD Commercialisation Technical Lead, you will work as a key technical leader within the Pharmaceutical CDS group.

You will be responsible for final pharmaceutical dosage form process development activities to support the commercialization of new products, implementing them into production, and driving process improvements in conjunction with R&D and the manufacturing Integrated Process Teams (IPT).

You will assemble and lead project technical teams for new process and product launches, ensuring that pharmaceutical processes are transferred to the IPT efficiently, compliantly, and completely.

Key Responsibilities

Bring your energy, knowledge, innovation, and leadership to carry out the following:

·Process Development & NPI Leadership: Lead the design, scale-up, and transfer of new solid oral dosage (OSD) manufacturing processes. This includes planning and executing characterization and design space studies, providing critical technical oversight for clinical and primary stability batch manufacture, and translating complex development data into robust, validated commercial processes.

·Cross-Functional Team Leadership: Lead and participate in high-performing, cross-functional teams to drive Quality Risk Assessments (QRA), complex Quality Investigations / Notifications, Safety Assessments (HAZOPs), and strategic process improvement initiatives.

·Validation Excellence: Author, execute, and lead process and cleaning validation programs to guarantee seamless compliance with cGMP, cleaning validation requirements, and global regulatory expectations.

·Technical Support & Troubleshooting: Provide high-level scientific and technical troubleshooting support to the IPT for multiple active manufacturing processes, evaluating raw materials, and ensuring process robustness.

·Project Management: Operate effectively as a project leader, using robust planning to identify needs, priorities, risks, and accountabilities to ensure successful outcomes for new product introductions and technology transfers.

·Continuous Improvement: Pioneer the application and sharing of cutting-edge techniques and processes. Identify and implement improvements in processes and business systems, utilizing Lean Six Sigma (LSS) tools to drive efficiency and optimization.

·Quality & Compliance: Ensure all engineering operations comply with cGMP, Environmental, and Health & Safety regulations. Act as a Sub-System Owner for various Quality Management System (QMS) areas, ensuring that all processes conform to site, divisional, and corporate quality standards.

Required Skills & Qualifications

·BSc, BEng, or higher in Chemical Engineering, Chemistry, Natural Sciences, or a related discipline. An advanced degree (MSc, PhD) is beneficial.

·A minimum of 6 years of post-graduation experience in a pharmaceutical process development, manufacturing, and technology transfer environment.

·Strong, demonstrated understanding of process chemistry, formulation technology, and engineering principles specifically applied to solid oral dosage (OSD) platforms.

·Expertise in process development, scale-up, technology transfer, and cleaning validation.

·In-depth knowledge of cGMPs, global regulatory expectations, and Quality Risk Management (QRM).

·Proven experience with deviation management systems, root-cause analysis (8-Step methodology), and production operations.

·Excellent written and verbal communication, with a proven ability to present complex technical data to diverse audiences.

·Demonstrated capability to lead project teams and work collaboratively across functional boundaries.

·Strong project management, problem-solving, and time-management skills.

·Ability to work in partnership with all plant departments, including PCT, process engineering, central engineering, and global manufacturing division groups.

Ballydine is the primary Drug Substance commercialisation hub within the network, where new processes are scaled and transitioned to commercial manufacture. The site supports clinical and commercial API supply and the transfer of processes and technologies across internal manufacturing sites and external partners.

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. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

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