Amgen Specialist Information Systems Analyst (Supply Chain) in Dun Laoghaire, 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.
IS Specialist GxP Operations & Digital transformation
As the IS Specialist GxP Operations & Digital transformation, you are the Information Systems contact person for site Supply Chain operation: Warehousing, Transportation and Distribution. You are driving the introduction and adoption of technologies which will advance business outcomes, e.g. Machine Learning, Internet of Things, Data analytics, and translate business needs to technology solutions. A key aspect is to deliver these in a GxP regulated environment using Agile methodology. You will oversee the delivery of quality compliance initiatives and commitments. Your proven experience with digital technology and business knowledge will enable you to liaise effectively with customers, vendors and IT experts, locally as well with Amgen functions worldwide to drive digital transformation.
Drive the advancement of digital transformation to support Site Supply Chain operations.
Advance the use of system capability and features to drive business efficiencies, process optimization and insights
Lead teams to conduct business analysis to identify business needs and partnering with business representatives to generate passion and engagement for digital technology
Expertise in translating business requirements into technical requirements and recommend solutions
Collaborate closely with multiple levels of leadership as well as peers to build alignment and advance initiatives
Ensures that systems are delivered in a compliant manner according to the IS quality system
Advise on robust remediation and resolution of deficiencies identified through internal audits, inspections and otherwise; follows up on closure of corrective and preventive action plans
Proactively identify and alert the IS organization of quality or compliance concerns in time to resolve adverse impact to the patient and company reputation
Bachelor or master’s degree in information systems, Computer Science or Life Sciences
7 years of Information Systems (IS) experience within the pharmaceutical or biotech industry (GMP/GDP)
Certified Scrum Master (PSM 1 and/or II)
Knowledge of global and healthcare regulations and quality standards and understanding of 21 CFR Part 11 Compliance
Experience with computer systems that support Manufacturing and Supply Chain operations e.g. , SAP, Manufacturing Execution Systems and Salesforce
Knowledge and experience with Warehouse, Site Supply Chain and Quality processes
Knowledge of change management and validation of computerized systems (e.g. GAMP5).
Experience with Agile projects
Excellent organization skills, detail oriented and accurate.
Skilled in working under pressure and must possess good time management skills.
Fluent in English (both verbal and written).
Able to communicate ideas in both technical and user-friendly language.
Experience in developing and executing SOPs, Installation and Qualification Testing Protocols.
Ability to work in global, cross-functional and virtual teams in different time zones (flexibility in work hrs.).
Experience in an International environment
Ability to work in a changing environment, under pressure, balancing multiple initiatives simultaneously
Proven analytical and problem-solving skills with attention to detail
Excellent communication and presentation skills
Strong IT skills and knowledge of different hardware, software and networks
Able to build a network with business partners
Ability to use logic and reasoning to identify the strengths and weaknesses of IT systems
Evaluating the functionality of systems
Providing user training, support, advice and feedback
Keeping up to date with new technology
Facility team’s meetings, sprint planning, sprint retrospectives and the daily stand-up
Helping the team in improving efficiency
Align team activities with stakeholders and balance scope, time and resources
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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.