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Technology transfer specialist

Dundalk
Independent Solutions
Posted: 14 November
Offer description

Job Title-Technology Transfer Engineer-Technical Operations (Extendable Contract)Overview:An exciting opportunity has arisen for aTechnology Transfer Engineerwithin the supportingDrug Substance Technical Operationsat a leading biopharmaceutical facility inDundalk.This position plays a key role in supporting technology transfer activities, process optimization, and continuous improvement within a biologics manufacturing environment. The successful candidate will work cross-functionally with Operations, Quality, and Engineering teams to ensure smooth and compliant technical transfer and ongoing commercial production.Key Responsibilities:Support and execute technology transfer activities for biologics drug substance processes.Author and review GMP documentation, including change controls, master batch records, protocols, reports, and regulatory filings.Provide on-site support during technology transfer and commercial manufacturing operations.Perform process data analysis to support process performance monitoring and continuous improvement.Lead and support investigations, deviation management, and process improvement initiatives.Partner with Operations, Quality, and Regulatory teams to ensure compliance with GMP standards and inspection readiness.Contribute to developing standardized work practices and sharing best practices across teams.Requirements:Bachelor's degree (or higher) in Science, Engineering, or a related discipline.Minimum 5 years' experience in a GMP manufacturing or technical support function (e.g., Operations, Technical Operations, Engineering, or MS&T).At least 3-5 years of hands-on experience in biological drug substance manufacturing or technology transfer is required.Strong communication, teamwork, and problem-solving skills.Desirable Skills:Experience managing or supporting projects independently within set timelines.Statistical or data analysis experience (e.g., process performance trending, CPV).Background in deviation management, change control, or equipment/process validation.Additional Information:Location: Dundalk, Co. Louth (onsite presence required at least 4 days per week).Duration: Project-based role & work planned till end of 2026.

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