Jurong West - Sr Manufacturing Technician.

apartmentThermo Fisher Scientific placeJurong West calendar_month 
Job Description
  • Setup and operate pharmaceutical production equipment, including high-speed filling lines for sterile products, autoclave, parts and vial washers, depyrogenation tunnel, formulation process, HMI and automatic CIP/SIP processes, and inspection and packaging line equipment (e.g., AVIM, labeling, and carton machine), as per relevant SOPs and Batch Record.
  • Complete formulation activities for production batches, including the formulation and/or dispensing of all available drug substance(s) and excipients.
  • Prepare, wash, and sterilize materials and parts.
  • Handle the packaging and transfer of final products to the freezer.
  • Complete all necessary training prior to task execution.
  • Perform all material and process (SAP) transactions at each manufacturing step.
  • Adhere closely to aseptic techniques and practices for aseptic operations.
  • Maintain and clean production equipment and classified areas.
  • Conduct routine QC sampling and in-process testing of the product at various manufacturing stages.
  • Timely completion of batch records and logbooks in adherence to GDP.
  • Transfer materials for batch manufacturing.
  • Prepare filters for test execution and perform FIT (Filter Integrity Testing).
  • Load and unload equipment during production activities.
  • Monitor stock levels of consumables and inform the Manager/Lead technician of material requirements.
  • Ensure safety and quality compliance at all times and report any anomalies to the Manager promptly.
  • Participate in EHS, Business Compliance, cGMP, and other compliance-related activities.
  • Report all quality issues immediately to the Manager or Lead technician.
  • Perform microbial sampling and swabbing of room and equipment if required.
  • Liaise with external vendors for instrument calibration and maintenance.
  • Conduct chemical and mathematical calculations to resolve product potency and endotoxin levels if necessary.
  • Inspect, label, and package finished drug products and perform in-process sampling and inspections on semi-finished products.
  • Undertake any other duties assigned by the Manager.
Education
  • Minimum O Level, NITEC/ITE education/Diploma in a relevant field.
Experience
  • 3 to 5 years of relevant experience in the pharmaceutical industry.
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