Sr Engineer

Category: Engineering
Job ID: R-70873
Employment Type: Full time
Location: Singapore Manufacturing – Tuas
Posted Date: February 8, 2019

SUMMARY

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.

This role will serve as a technical lead for the Biotechnology Manufacturing facility in ASM for the facilities and engineering team. It will provide advance technical support to complex engineering equipment and processes. The role will be a liaison between corporate engineering and site operations in the design and implementation of new equipment and/or equipment modifications. Experience in design, qualification, operation, maintenance and improvement of biopharmaceutical equipment will be required to support day to day manufacturing activities as well as to lead improvement projects. Overall biopharmaceutical processes knowledge will be required to perform complex troubleshooting activities. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, process and/or capital projects. Develops, organizes, analyses and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. This role is crucial for Amgen’s success and it will be a key contributor in the ASM-1 area.

SPECIFIC RESPOSABILITIES INCLUDE BUT ARE NOT LIMITED TO:

General:

Equipment / Process Equipment knowledge to perform complex troubleshooting of equipment failures or malfunctions and/or the development of technical assessments. General knowledge on Biopharmaceutical operations and processes such as Media / Buffer Prep solutions, Inoculation, Bioreactors, Harvest, Chromatography and Tangential Flow Filtration as well as Clean 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. Experience in cleaning validation execution and 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. Develop engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis. 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. Experience in investigation of non-conformances, development of corrective and preventive actions and generation and implementation of change controls.

Design Engineering:

Experience in Design processes such as development of business case, project charter, user requirements, quality risk assessments, conceptual design, BOD’s, preliminary design, design specifications and detail design. Commissioning and qualification experience in activities such as FAT, SAT’s, automation checkouts, IQ-OQ-PQ and spare parts definition. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints. Coordinate the work of consultants, architects and engineering firms on development of standard design documents. Develop project budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

** Other functions may be assigned

Basic Education & Experience

  • Master’s degree in Engineering & 4 years of experience in pharmaceutical company or GMP environment

    OR

  • Bachelor’s degree in Engineering & 6 years of experience in a pharmaceutical company or GMP environment

    OR

  • Undergraduate diploma in Engineering & 8 years of experience in a pharmaceutical company or GMP environment

    Preferred Qualifications

  • Working knowledge of pharmaceutical/biotech processes such as bioreactors, chromatography, buffer / media tanks, single use technologies and critical utilities.
  • Ability to perform troubleshooting / advance engineering assessments for a biotechnological manufacturing processing equipment.
  • Familiarity with documentation in a highly regulated environment.
  • Ability to interpret and apply GLPs and GMPs.
  • Ability to apply engineering science to production.
  • Ability to apply engineering science in the analysis and development of maintenance programs for production equipment’s.
  • 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.
  • Comprehensive understanding of validation protocol execution requirements.
  • Demonstrated Skills in the following areas:
    • Basic technical presentations.
    • Personal Organization.
    • Validation Protocol Writing.
    • 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.
  • Interacts effectively with variety of communication and working styles.
  • Ability to independently determine when additional internal resources are required to solve problems.
  • 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
  • Established expertise in at least 3 separate areas of engineering technology such as equipment design/operation/maintenance, automation, process engineering, project management and/or validation.
  • Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
  • Working knowledge of financial analysis tools.
  • Ability to delegate and manage the project work of others.
  • 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
  • Management of contractors and vendors.
  • Flexibility to work off-hours.

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