Amgen Mfg Process Technician in Singapore, Singapore

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

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