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Job Description
Senior Technology Transfer Engineer sought for a leading Global Biopharmaceutical in Cork, Ireland. The ideal candidate will support technical delivery of NPI and TT projects, ensuring compliance with specifications, regulatory guidelines, and right first-time delivery.
Key responsibilities include:
- Representing as the technical SME for Drug Product filling operations and building strong partnerships within the company network in a matrix team environment.
- Overseeing new product introductions at the company site, from development batches to approval and commercialization.
- Supporting aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management.
- Leading risk assessments in support of product(s) technology transfers.
- Developing data-driven strategies for process development/product characterisation.
- Authoring technical reports to support Drug Product Technology Transfer and Drug Product Process and Product Characterization.
- Developing design of experiments for execution of lab studies/analytical work with a high level of autonomy.
- Managing change control, deviations, and CAPAs through the quality management system.
- Supporting on-site implementation of changes and Drug Product launch activities.
- Supporting investigations, facilitating root cause analysis for deviation resolution, data gathering/analysis, and providing technical assessments for deviations.
- Assisting PPQ Campaign readiness and in-person, on the floor execution support for Technical runs and PPQ campaigns.
- Initiating and leading process improvement projects, involving cross-functional teams.
- Authoring CMC sections of US and international regulatory dossiers, drafting responses to health agency requests during health agency review.
- Supporting regulatory inspections and presenting technical topics during inspections for process-related aspects of assigned products.
- Supporting development of Drug Product global technical policies, standards, and guidelines.
- Ensuring personal understanding of all quality policy/company system items.
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.
- 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 periods during execution of technical protocols.
- Proficient in MS Office: Word, Excel, Outlook, Power Point, MS Project etc.