• 
  Part of the Micro/EM Team responsible for the following:
• 
  Performance of
  testing of EM / product stream samples to meet product release timelines and in
  accordance with cGMP regulations and Roche/Genentech standards.
• 
  Support
  manufacturing operations by timely completion of testing and disposition.
• 
  Continuous
  improvement of processes and technology, in collaboration with ASAT, to drive right
  first time and efficiencies.
• 
  Qualification and
  validation of test methods.
• 
  Supporting
  investigations of microbial contamination in production processes, classified
  environments, and critical utility systems.
• 
  Ensuring test
  methods and data are generated in a compliant manner following cGMPs.

• 
  Testing and review of routine and non-routine environmental, raw material, product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).
• 
  Perform EM which includes HVAC / BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases and water / clean steam sampling in accordance to cGMP procedures when required.
• 
  Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
• 
  Prepare EM reports / trend graph for product lot release and trend data analysis.
• 
  Review routine data and logbooks.
• 
  General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.
• 
  Problem solving of testing related issues as well as troubleshooting of equipment.
• 
  Author and/or update existing SOPs, Forms, OJTs and TMs as needed.
• 
  Initiate discrepancy record, perform discrepancy assessment and identify corrective actions where necessary.
• 
  Train other analysts on methods and/or SOP.
• 
  Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
• 
  Participate in internal / external audits and regulatory inspections.
• 
  Raise work notification, g2g shopping cart for
  purchase of consumables / reagent / media for Lab use. Follow up on the planned
  receipt, Delivery orders, invoices when required.
• 
  Understanding of basic microbiological
  principles (bioburden, LAL, plating and counting techniques, etc) and execution
  of intermediate techniques (DET, AET).
• 
  Participate in
  project, validation and process improvement works.
• 
  Perform equipment qualification / maintenance,
  liaise with external / contract lab / vendor.
• 
  Contribute to the continuous improvement of
  laboratory procedures and processes to ensure compliance to GMPs.
• 
  Provide forecast for consumables / reagent /
  media used and facilitate in budgeting and financial planning.
• 
  Perform sample receipt and storage of QC
  samples.
• 
  Manage the life-cycle process for retain and
  reserve/reference samples.
• 
  Manage and prepare the shipment of samples to
  Receiving labs.

• 
  Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team’s objectives/goals, takes the initiative and proactively turn ideas into action – to make things happen.
• 
  Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
• 
  Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
• 
  A team player and the willingness to cover other colleagues in continued support of the Micro/EM operations.

• 
  Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• 
  Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

• 
  Embody
  PT Lean Production System (LPS), while demonstrating a continuous improvement
  mindset and behaviors through the use and application of LPS tools for
  continuous improvement initiatives.

Requirements

• 
  Degree
  in Microbiology, Biology, Biochemistry or any Life
  Sciences discipline or equivalent
• 
  1-3
  years of related working experience for degree holders or
  equivalent holders with combination of education and
  relative work experience
• 
  Related
  working experience in a biotech or pharmaceutical
  operating environment is a plus

• 
  Knowledge
  of cGMP relevant to the pharmaceutical industry
• 
  Knowledge
  of laboratory safety procedures
• 
  Able
  to determine when to escalate issue
• 
  Ability
  to organize and plan effectively
• 
  Good
  team player
• 
  Demonstrate
  excellent verbal and written communication skills in English