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Manufacturing Process Technician - Singapore  

Amgen (company)

Posted on : 01 May 2017

Project Description

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

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