Instrument Equipment Specialist

The Instrument Equipment Specialist oversees, coordinates and executes all activities pertaining to instruments, equipment, systems and facilities to ensure good science and compliance with GXP and government regulations.

Responsabilites:

  • Develop and maintains up to date schedule of annual certification, maintenance and calibration of laboratory equipment and systems.
  • Maintain logs and required documentation for qualification, validation and maintenance/repair of instruments/equipment, as per standard Operating Procedures.
  • Develop and maintain a standardized equipment, spare parts and user manuals inventory.
  • Develop and execute (or supervise outsourced execution) calibration/maintenance procedures and/or qualification protocols related to equipment and systems.
  • On a daily basis, ensures proper functionality of laboratory equipment and systems based on theory of operation, maintenance, trouble-shooting and effective repair procedures.
  • Prepare technical reports with recommendations for solutions to technical problems.
  • Prepares propositions and related quotes and coordinates activities for installation of new laboratory equipment/systems.
  • Advice management on what improvements need to be made to reduce instrumentation/equipment failure rate, improve productivity, service quality, cost saving and new policies and procedures.

Skills and experience required

  • DEC in Biomedical or Electronics Technology or a bachelor’s degree in a scientific discipline or equivalent of 5-10 years related experience.
  • Minimum of 5 years in the pharmaceutical industry or regulated environment
  • Experience in Quality Assurance or Quality control and validation in the pharmaceutical industry.
  • Knowledgeable of Analytical instruments, worked in a laboratory environment
  • Strong technical writing skills
  • Knowledgeable of Good manufacturing practices, Health Canada and FDA
  • Organised, structured and detail oriented
  • Good communication skills and excellent Team worker
  • Good knowledge of MS office
  • Bilingual (French and English)
  • Experience in dealing with regulatory agencies (an asset)
  • Hands experience on instrument qualification and very well familiar with Risk Based approach

Application for the position of Instrument Equipment Specialist

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