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Work Schedule:
Need to be able to work 12 hour shifts (5:45 AM to 6:15 PM OR 5:45 PM to 6:15 AM)
Need to be able to work weekends (See work week schedule below which alternates 3 days and 4 days each week)
Objectives:
Perform and document daily manufacturing operations according to SOP’s in a cGMP environment
Operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels)
Execute validation protocols
Create or revise cGMP documents
Accountability:
With general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels.
Perform basic trouble shooting
Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems
Documents cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks.
Executes batch records and validation protocols under supervision/direction of others
Author and review equipment use logs
Performs inventory transactions in SAP
Performs data entry into LIMS
Accountable for completing assigned trainings within required timeline and actively participate in training activities.
Stock production and cleaning supplies
Perform cleaning/sanitizing production rooms and equipment
Knowledge, competencies and skills:
Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred
Familiar or experience with cGMP within Biotech or Pharmaceutical operations preferred
Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus
Prior experience with lab equipment a plus
Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
One of the largest pharmaceutical company in Asia and one of the top 20 largest pharmaceutical companies in the world by revenue.