Summary
Our client, a biopharmaceutical company located in Louth, is looking for a Technology Transfer Engineer to support Drug Product activities within a growing technical operations team. The successful candidate will contribute to technology transfers, commercial manufacturing support and process optimisation across formulation, filling, lyophilisation, capping and automated visual inspection. This role offers strong exposure to cross-functional collaboration and the opportunity to act as a subject matter expert for key Drug Product processes.
Responsibilities
- Support technology transfer activities by preparing, reviewing and executing GMP documentation, including master batch records, protocols, reports and change controls.
- Provide technical support for Drug Product operations such as formulation, filling, lyophilisation, capping and automated visual inspection.
- Act as process owner for assigned areas, demonstrating technical expertise and ensuring robust, compliant processes.
- Lead or support investigations, atypical event assessments and root-cause analysis, ensuring effective CAPA development and implementation.
- Analyse process performance using statistical tools and identify opportunities for improvement, optimisation and standardisation.
- Support Commercial and Technology Transfer activities through on-the-floor technical assistance and person-in-plant engagement.
- Ensure compliance with GMP requirements and regulatory expectations, collaborating closely with Operations, Quality and Regulatory functions.
- Contribute to inspection readiness activities and participate in audits as required.
- Share best practices and support continuous improvement initiatives across the site.
Qualifications & Experience
- Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Sciences, Chemistry, Biology or related field.
- Minimum 3 years' experience in a GMP environment within operations, engineering, technical operations, MS&T, or a similar function.
- Experience in aseptic operations, process development, analytical support or technology transfer.
- Knowledge of regulatory frameworks such as Annex 1 and relevant industry guidance.
- Experience with lyophilised products and start‑up or scale‑up environments.
- Background in deviation management, change control, equipment support or qualification.
- Proficiency in statistical tools for process monitoring and continuous improvement.
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