Amgen Sr. Process & Equipment Engineer in Dublin, Ireland
Process & Equipment Engineer
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. The candidate will have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering relating to systems and equipment and associated automation systems.
Ownership of equipment/systems in a GMP regulated manufacturing setting
Support Drug Product manufacturing within the Syringe Filling area
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
Monitoring of day-to-day performance of their assigned system. Troubleshooting of performance trend
Data trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends.
Ensuring the preventive maintenance schedule for their system is successfully implemented.
Ensuring that a critical spare parts list for their system is identified and appropriate levels of spares are maintained.
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
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.