Amgen Specialist IS Automation in Dublin, Ireland
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 Operations Information Systems (OIS) team, the role will support critical systems running automated manufacturing processes.
Application ownership, administration and maintenance of key platforms in a GMP regulated manufacturing setting e.g. Process Control System (PCS), Building management System (BMS) and Serialisation platforms
Support Drug Product manufacturing within the Formulation, Vial/Syringe Filling, Lyophilisation, Component Preparation, Inspection and Packaging
Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures
Lead technical root cause analysis, incident investigations and troubleshooting issues related to system performance and reliability
Work in partnership with the site Engineering Automation team to ensure overall system availability, reliability and continuous improvement
Lead and support lifecycle management of systems in line with corporate programs
Lead and support execution of IS projects and IS and deliverables for site and capital projects
Advance the use of system capability and features to drive business efficiencies and process optimisation
Accountable for overall platform architecture, ensuring alignment with OIS standards
Accountable for interfaces between systems in the technology stack
Accountable for application compliance, user administration, Disaster Recovery, OS & Application Patching
Advancement and maintenance of cyber security controls for manufacturing systems
Ensuring licencing and maintenance agreements are in place for all platforms, including those supporting OEM systems
Solving complex problems, 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 and Experience
Bachelor’s in electrical engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 5+ years’ experience in operations/manufacturing environment
Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
Excellent knowledge and experience supporting various aspects of Manufacturing Automation Platforms from an IT perspective including system architectures, database philosophies, cyber security, IT hardware, networking, system interfacing and integration
Experience in Allen Bradley PLC programming and troubleshooting, Rockwell Automation Platforms e.g. SCADA and Batch Systems (Factory Talk View and Factory Talk Batch), ControlNet (CNET) and DeviceNet networking, RSLinx Classic and Enterprise, RSNetworx, FactoryTalk AssetCentre, ThinManager Software, and OSIsoft PI Data Historian, Systech serialisation
Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11
Strong network architecture or engineering proficiencies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration, Firewalls and Cyber Security technologies
Solid leadership, technical writing, and communication/presentation skills
Experience in change control, non-conformance, corrective and preventative actions, and validation practices
Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
Ability to influence the development of business area strategy and IT strategy where appropriate
Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements
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 disease, 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.