Amgen Associate Engineer in Singapore, Singapore
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has 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.
The Engineer is overall responsible as a System Owner for several Biotechnology process equipment and single use systems as well as provide technical support to day-to-day manufacturing activities. The role will be a liaison between manufacturing, maintenance, engineering and automation in the troubleshooting and resolution of equipment related issues.
Experience in design, qualification, operation, maintenance and improvement of Biotechnology manufacturing equipment will be required to support day to day manufacturing activities as well as to lead improvement projects. Overall Biotech processes knowledge will be required to perform complex troubleshooting activities. This role is crucial for Amgen’s success and it will be a key contributor in the ASM-1 (Biotech) facility.
Equipment System Owner
Responsible for operation and reliability of Biotechnology process equipment and single use systems assigned.
Apply process equipment knowledge to perform troubleshooting of equipment failures/malfunctions and the development of technical assessments.
Develop, implement and optimize maintenance and reliability activities such as preventive maintenance, job plan and datasheet development.
Apply knowledge of Operational Excellence practices such as lean maintenance to drive continuous improvement.
Responsible for investigation of deviations, development of corrective and preventive actions and implementation of change controls in a timely manner.
Responsible for completion of process equipment periodic review, data integrity assessment and security assessment in a timely manner.
Complete complex or novel assignments requiring development of new and/or improved engineering technologies, techniques and procedures.
Serve as a peer-recognized engineering technology specialist.
Collect, organize, analyze and present results for operational issues or engineering projects of various scale and complexity.
Work independently and/or with project managers to complete engineering projects of various scales within schedule, budget and quality constraints.
Responsible for commissioning and qualification activities including FAT, SAT, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment.
Participate in the system walkdown, ensure the closure of punch items and support the takeover of the system from the project team.
Master’s degree OR
Bachelor’s degree and 2 years of directly related experience OR
Associate’s degree and 6 years of directly related experience OR
High school diploma / GED and 8 years of directly related experience
Experience in Biotechnology process/equipment such as Bioreactors, Chrom Skids, ATF/TFF and Single Use Systems.
Knowledge of automation and control systems such as Delta-V and PLC.
Familiarity with documentation in a highly regulated environment.
Problem solving skills requiring the application of scientific/engineering theory and calculations and creative skills in the development of hypotheses and approach.
Demonstrated skills in the following areas:
Problem solving and applied engineering.
Basic technical report writing.
Basic technical presentation.
Dealing with and managing change.
Technical (Equipment Specific).
Analytical problem solving
Ability to develop solutions to technical problems.
Computer Literacy(Maximo, Track wise, E-Builder, PCS and QEMS).
Ability to handle multiple projects at the same time with demonstrated skills in the following areas: Able to develop solutions to routine technical problems.
Basic project management including schedule development, facilitation, collaboration, completion and follow-up.
Management of contractors and vendors.
Experience in validation processes such as generation/execution of installation/operation/performance qualification documentation.
Flexibility to work off-hours.
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.