Amgen Engineer - System Owner 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 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.

The Engineer is overall responsible as a System Owner for several Biologic Manufacturing Equipments as well as provide technical support to day-to-day manufacturing activities.

The Engineer will provide technical support to complex manufacturing equipments and processes. The role will be a liaison between manufacturing, maintenance and engineering 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.

SPECIFIC RESPOSABILITIES INCLUDE BUT ARE NOT LIMITED TO:

Equipment System Owner

  • Responsible for system operation and reliability of Biotechnology Process equipment assigned.

  • Process Equipment knowledge to perform troubleshooting of equipment failures or malfunctions and/or the development of technical assessments.

  • General knowledge on Biotechnology manufacturing operations and processes such as Bioreactors, Chrom Skids, ATF/TFF, Single Use Systems and critical utilities.

  • Knowledge in Automation systems and processes such as RD's, Delta-V, BMS, ladder logic and PLC.

  • Strong knowledge in the design of maintenance and reliability activities such as job plan, data sheets and equipment reliability technology.

  • Experience in validation processes such as Generation / Execution of Installation / Operation / Performance qualification documentation.

  • Knowledge of Operational Excellence practices such as lean manufacturing and lean maintenance.

  • Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.

  • Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.

  • Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.

  • Serves as a peer-recognized engineering technology specialist with overall responsibility for determining methodologies in that area.

  • Application of mature engineering knowledge in planning and conducting projects.

  • Prompt and regular attendance to workplace.

  • Demonstrate project management skills and application of concepts.

  • Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

  • Experience in investigation of non-conformances, development of corrective and preventive actions and generation and implementation of change controls.

Design - Project Engineering:

  • Commissioning and qualification experience in activities such as FAT, SAT's, automation checkouts, IQ-OQ-PQ and spare parts definition.

  • Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.

  • Participate in the system walkdown, ensure the closing of punch items and support the takeover of the systems from the Project team

  • Interface with Commissioning team to support the commissioning of all Utilities system.

Basic Education & Experience

Master's degree OR

Bachelor's degree & 2 years of directly related experience OR

Associate's degree & 6 years of directly related experience OR

High school diploma / GED & 8 years of directly related experience

Preferred Qualifications

  • Working knowledge of Biotechnology process equipment such as Bioreactors, Chorm Skids, ATF/TFF and Single Use Systems.

  • Familiarity with documentation in a highly regulated environment.

  • Able to develop solutions to routine technical problems.

  • Demonstrated skills in the following areas:

  • Problem solving and applied engineering.

  • Basic technical report writing.

  • Verbal communication.

  • Demonstrated Skills in the following areas:

  • Basic technical presentations.

  • Personal Organization.

  • Dealing with and managing change.

  • Technical (Equipment Specific).

  • Analytical Problem Solving.

  • Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS).

  • Specialized equipment/process expertise.

  • Ability to handle multiple projects at the same time.

  • Demonstrated Skills in the following areas:

  • Schedule development

  • Facilitation

  • Collaboration

  • Basic project management

  • Completion and follow-up

  • Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.

  • Demonstrated Skills in the following areas:

  • Negotiation, persuasion and facilitation Collaboration

  • Project Cost development

  • Conflict Resolution

  • Leadership and team building

  • Schedule and resources loading development

  • Customer service in a technical setting

  • Management of contractors and vendors.

  • Flexibility to work off-hours.