SummaryOur client, a leading biopharmaceutical company based in Dundalk, is seeking a Technology Transfer Engineer to join their Manufacturing Science and Technology (MS&T) team. The successful candidate will support the transfer and implementation of biological drug substance manufacturing processes from development or other sites into commercial production. The role will also involve providing technical support to ongoing manufacturing operations, ensuring robust process performance and continuous improvement within a GMP-regulated environment.ResponsibilitiesWork with Internal Partners to deliver technical transfer of our drug substance programResponsible for technical activities for the commercial manufacturing process, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.Provide on-site coverage in support of Technology Transfer Person-In-Plant Activities.Translate understanding of GMP requirements and current regulations and develop standardised work to meet these requirements by partnering with Operations, Quality, and other Internal Partners.Ensure that External Partners are inspection-ready for all routine inspections and/or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.Responsible for participation in creating, sharing, and adopting best practices and business process strategies.Qualifications & ExperienceDegree in Chemical Engineering, Biotechnology, Biochemistry, or a related scientific or engineering discipline.Minimum of 3 years’ experience in a GMP-regulated biopharmaceutical, biotechnology, or pharmaceutical manufacturing environment.At least 2 years of experience in drug substance manufacturing, technology transfer, or process development.Strong knowledge of GMP, regulatory compliance, and industry guidelines (e.g., ICH, FDA, EMA).Proven experience in authoring and reviewing technical documentation, investigations, and validation protocols (IQ/OQ/PQ).Experience with statistical analysis, process performance evaluation, and data management tools.
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