Job Description
Elusavrecruitment have an amazing opportunity for a Senior Technology Transfer Engineer with a leading Global Biopharmaceutical in Cork, Ireland. As the Technology Transfer Engineer you will support technical delivery of NPI and TT projects through close collaboration with cross functional project teams, ensuring compliance with specifications, regulatory guidelines, and right first-time delivery. Responsibilities: Represent as the technical SME for Drug Product filling operations and build strong partnerships within the company Network in a matrix team environment. Key team member to oversee new product introductions at the company site, from development batches to approval and commercialization. Support aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management. Lead risk assessments in support of product(s) technology transfers. Develop data driven strategies for process development / product characterisation. Author technical reports to support Drug Product Technology Transfer and Drug Product Process and Product Characterization. Develop design of experiments for execution of lab studies/analytical work with a high level of autonomy. Own change control, deviations, and CAPAs until closure, through the quality management system as needed. Support on-site implementation of changes and Drug Product launch activities. Support investigations, facilitate root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations. Assist PPQ Campaign readiness and in-person, on the floor execution support for Technical runs and PPQ campaigns. Initiate and lead process improvement projects, involving cross-functional teams. Author CMC sections of US and international regulatory dossiers, draft responses to the heath agency requests during health agency review. Support regulatory inspections and present technical topics during inspections for process-related aspects of assigned products when necessary. Support development of Drug Product global technical policies, standards, and guidelines as needed. Ensure personal understanding of all quality policy/company system items that are per training curriculums. Other duties as assigned. Requirements: A degree in engineering or science with a minimum 3+ years of relevant experience in biotech/pharmaceutical field. Strong understanding and hands on experience in MSAT or process development or technology transfer, background in large scale processing of biologic drug products. Understanding of regulatory requirements and guidelines. Proficient in technical writing is needed. Ability to find, communicate, and implement ways to continuously improve processes. Ability to multi-task and manage tight timelines in a fast paced environment. Ability to work on the manufacturing floor for extended period during execution of technical protocols. Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project etc. Contact: If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on or . Skills: decision-making technical writing team player