Manufacturing Process Specialist

November 5 2018
Industries Pharmaceutical, Biotechnology
Categories Production, Operations, Quality, Safety, Pharma, Biotech, Sciences, R&D, Chemical, Pharmaceutical, Research & development, Chemistry, Production and planning management, Operations (manufacturing, packaging), Research and development
Saint-Laurent, QC

Summary of functions 

As a subject matter expert in manufacturing equipment, the manufacturing process specialist is responsible to define equipment train, and evaluate and implement necessary equipment needed for the development of new semi-solid dosage products.

Main roles and responsibilities 

  • Provides Manufacturing expertise and project support to the project managers, clients and other stakeholders,
  • Perform process capability and gap analyses on new processes,
  • Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling,
  • Adapt machine or equipment design to production conditions,
  • Lead/support procurement and commissioning of new manufacturing equipment,
  • Draft and execute documentation for equipment validations including IQ, OQ, and PQ protocols as well as risk assessments, and/or manage external resources performing these activities,
  • Create/revise existing/new SOP's for equipment and processes,
  • Devise and execute process optimization experiments (Design of Experiments),
  • Prepares Master Batch Records for Product Development Services and Commercial Operations. Drives required changes to Master Batch Records through change controls as required,
  • Leads and/or participates in problem solving and investigations for manufacturing activities, equipment and processes,
  • Conduct technical review of completed records and protocols,
  • Provide on-the-floor oversight of the manufacturing and packaging process, as necessary,
  • Provide technical training as necessary to operators,
  • Other duties as perceived and agreed upon by senior management.

Minimum educational requirements 

  • Bachelor's degree (Chemistry or chemical engineering or related technical/scientific field) from a Canadian University, or an equivalent scientific diploma recognized by a Canadian University or an accredited Canadian organism.

Minimum experience 

  • Minimum of ten (10) years of experience in in a cGMP environment,with a minimum of five (5) of experience in semi-solid dosage form manufacturing.

Minimum skills requirements 

  • Expert knowledge of modern pharmaceutical drug product (bulk) manufacturing processes,
  • Full professional proficiency in English required,
  • Strong problem solving and technical writing skills,
  • Proficient in Process Safety concepts and methodology,
  • Proficient in Commissioning and Validation strategies and execution,
  • Has excellent verbal and written communication skills,
  • Able to lead and assist in training others,
  • Able to be flexible and adapting to manufacturing schedules.
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