Associate Mfg I
Amgen
Singapore, , SG
1d ago

Perform solution and equipment preparation, raw material and single use parts dispensing for manufacturing processes in mammalian cell culture and purification processes.

Responsibilities :

  • Involve in hands-on execution of the plant operations and assist Manufacturing Associates in trouble-shooting
  • Monitor and analyze processing parameters for atypical trends and improvement opportunities
  • Perform solution and equipment preparation
  • Perform raw material and singe use parts staging and dispensing with additional logistical support responsibility
  • Stage components for autoclaving and washing
  • Perform filter integrity testing of sterilising filters
  • Perform environmental monitoring of classified manufacturing cleanroom
  • Support in-process testing of production samples, prior experience with analytical instrument will be a plus point
  • Actively support continuous improvement initiatives
  • Support Safety audits
  • Adhere to any applicable EHS requirements
  • Ability to adhere to regulatory requirements, written procedures and safety guidelines
  • Ability to evaluate documentation / data according to company and regulatory guidelines
  • Ability to interact with inspectors (internal and external)
  • Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
  • Basic statistical mathematical skills
  • Ability to organize work and handle multiple priorities and meet deadlines
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • Regulatory knowledge
  • Understanding of analytical methods
  • All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

    Basic Qualifications :

  • NTC / ITC / Diploma in Chemical, Pharmaceutical, Life Sciences or Bio-processing related disciplines
  • Possess minimum 0 - 2 years of relevant experience in the biotechnology, pharmaceutical or petrochemical industry. Fresh graduates will be considered.
  • Knowledge of plant and unit operations (autoclave, parts washers, process equipment), good problem solving skills
  • Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation
  • Strong analytical skills with knowledge of Lean and Six Sigma
  • Excellent self-motivated team player with hands-on attitude and good communication skills
  • Experience with Emerson DeltaV, LIMS, TrackWise
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • Ability and willingness to work any shift in support of operations that may include 24 / 7
  • Mechanical ability / expertise
  • Join Us

    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.

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