Production Technician III

Piramal Pharma LtdAurora, ON

About The Position

Contribute to the small scale (Pilot Plant & Kilo Lab) production of active pharmaceutical ingredients and intermediates in a safe and efficient manner that is compliant with current Good Manufacturing Practices (cGMP), government regulations and meets customer’s expectations. Perform all duties regarding batch process with minimal direction from a senior level Technician according to Standard Operating Procedures (SOP’s).

Requirements

  • Contribute to the small scale (Pilot Plant & Kilo Lab) production of active pharmaceutical ingredients and intermediates in a safe and efficient manner that is compliant with current Good Manufacturing Practices (cGMP), government regulations and meets customer’s expectations.
  • Perform all duties regarding batch process with minimal direction from a senior level Technician according to Standard Operating Procedures (SOP’s).
  • Loading/unloading vessels
  • Transferring liquids and solids between vessels
  • Charging liquids and solids to a vessel
  • Performing gas additions from pressurized cylinders
  • Completing batch filtrations and distillations (e.g. Vacuum distillations) while monitoring parameters
  • Operation of process equipment (e.g. pumps/hoses, sparkler filters, robot filters, scrubber systems, Heating/Cooling units and Prax-air sytem (Pilot Plant only)
  • Completing production related documentation
  • Provide basic troubleshooting on manufacturing equipment and processes in areas of qualification in conjunction with a senior level Technician
  • Dismantle, clean, assemble and set-up production equipment and complete cleaning logs
  • Sample materials and products by reviewing and preparing documentation, preparing the sampling and protective equipment, obtaining the sample and submitting to Quality and Compliance function
  • Maintain cleanliness and order of work area to ensure cGMP and safety compliance
  • Package, apply labels and lot numbers to identify batches
  • Handle skin sensitised product while ensuring good hygiene practices
  • Actively train on SOP’s, Technical Manuals and safety procedures as required
  • Document and record all necessary information/data as per SOP and GMP requirements (e.g. batch sheets, logs, equipment ID cards etc.)
  • Provide guidance to other Production Technicians as required
  • Participate in opportunities to develop industry relevant production knowledge
  • Act as an operations department representative on cross-functional teams regarding validation, process optimisation problem products, etc.
  • Practice compliance with cGMP and safe operations (e.g. wearing Personal Protective Equipment including self-contained breathing apparatus and cartridge respirators
  • Perform other duties as assigned

Responsibilities

  • Loading/unloading vessels
  • Transferring liquids and solids between vessels
  • Charging liquids and solids to a vessel
  • Performing gas additions from pressurized cylinders
  • Completing batch filtrations and distillations (e.g. Vacuum distillations) while monitoring parameters
  • Operation of process equipment (e.g. pumps/hoses, sparkler filters, robot filters, scrubber systems, Heating/Cooling units and Prax-air sytem (Pilot Plant only)
  • Completing production related documentation
  • Provide basic troubleshooting on manufacturing equipment and processes in areas of qualification in conjunction with a senior level Technician
  • Dismantle, clean, assemble and set-up production equipment and complete cleaning logs
  • Sample materials and products by reviewing and preparing documentation, preparing the sampling and protective equipment, obtaining the sample and submitting to Quality and Compliance function
  • Maintain cleanliness and order of work area to ensure cGMP and safety compliance
  • Package, apply labels and lot numbers to identify batches
  • Handle skin sensitised product while ensuring good hygiene practices
  • Actively train on SOP’s, Technical Manuals and safety procedures as required
  • Document and record all necessary information/data as per SOP and GMP requirements (e.g. batch sheets, logs, equipment ID cards etc.)
  • Provide guidance to other Production Technicians as required
  • Participate in opportunities to develop industry relevant production knowledge
  • Act as an operations department representative on cross-functional teams regarding validation, process optimisation problem products, etc.
  • Practice compliance with cGMP and safe operations (e.g. wearing Personal Protective Equipment including self-contained breathing apparatus and cartridge respirators
  • Perform other duties as assigned
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