Amgen Specialist Information Systems (Quality & Laboratory Systems) in Dublin, Ireland
Education requirements are a Bachelors degree in Engineering, Information Systems, Computer Science or the Life Sciences. The successful candidate will have at least 5 years experience providing Quality and/or Laboratory information systems solutions and support to manufacturing organizations in the biotechnology or pharmaceutical industries. This position will be based in the Amgen Dun Laoghaire Facility in Dublin, Ireland.
The candidate will provide support for existing Quality and Laboratory information systems and will lead the implementation of new Quality and Laboratory information systems. This role has the following accountabilities and responsibilities
Develop support plans for systems including any required contracts with vendors or third parties, ensure all parties are aware of their responsibilities
Ensures that systems are robust, reliable and available to meet business demand
Ensures that systems are maintained in a compliant manner according to the IS quality system
Ensures systems have appropriate disaster recovery plans and processes including contingency plans
Develop lifecycle plan for Quality and Laboratory Systems
Proactively engage with Quality and Laboratory teams to encourage the use of technology to maximize efficiency, capacity and reliability or operations
Develop innovative approaches to solve business challenges with current or new technology
Plan and execute Quality & Laboratory information systems projects including the building configuration of PC’s for use in a GLP environment according to GAMP 5 and CFR 21
Coach system users in the complaint and efficient use of their systems
Aligns with relevant corporate business and IS teams to ensure that IS strategy for Quality and Laboratory systems is aligned with Amgen goals and standards
The individual will be capable of providing technical leadership to the site while ensuring that new initiatives are well defined, have a valid business case and are aligned with similar initiatives within Amgen.
Candidates should demonstrate technical, project and interpersonal skills, including but not limited to the following: client interfacing and resolution of client concerns, project definition and business case development, proactive support and resolution of issues, technical guidance from concept to delivery, system delivery, commissioning and validation.
Individual must be able to work independently with minimal supervision.
Candidates must have demonstrated experience in the delivery and management of information systems in addition to a working knowledge of GAMP software development lifecycle, and appropriate development methodologies for information systems.
Experience with Empower CDS, Gen 5, Tecan, Maldi Biotyper, Tiamo, LMES, Sample Manager LIMS, Laboratory Analytical Equipment and instruments and Trackwise will be an advantage.
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.