Process & Equipment Engineer Job Description Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities - Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. The ADL site also includes laboratories and cold chain warehouse capabilities. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people's lives. Amgen is developing the capability to produce all of its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally. As a member of the Process & Equipment Engineering team, the role will support complex and challenging manufacturing initiatives. Key Responsibilities Ownership of equipment/systems in a GMP regulated manufacturing setting Support Drug Product manufacturing within the Formulation, Vial/Syringe Filling, Lyophilisation, Inspection, Component Preparation and Packaging areas Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs Solving complex problems, project management, equipment lifecycle management and operational excellence Develop and manage change control requests per established SOPs and processes Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations Preferred Qualification Bachelors in Engineering (Mechanical, Electrical or Chemical) Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities Solid leadership, technical writing, and communication/presentation skills Experience in change control, non-conformance, corrective and preventative actions, and validation practices Experience in developing strategies for new product introduction and new technology deployment Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate Ensure application of corporate blueprint and standards using business drivers to local business needs Development and presentation of project plans to senior management Day to day vendor management and contract negotiations with focus on equipment suppliers Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making Travel at various times may be required to support execution of projects To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
