Bioprocess Engineering Specialist

4 weeks ago

Toronto, Ontario, Canada Hyde Engineering + Consulting Full time

The Bioprocess Specialist will play a crucial role in the design phase of a new production facility. This position involves supporting Factory Acceptance Tests (FAT) off-site, overseeing construction, conducting Site Acceptance Tests (SAT), and providing field engineering during the final stages of the project.

Key Responsibilities

  • Lead and support the design and specification of cGMP equipment, processes, and utilities for biopharmaceutical projects.
  • Develop and review essential project documentation including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Technical Specifications.
  • Create and evaluate process models and perform sizing calculations for process equipment and control valves.
  • Manage and maintain comprehensive lists and data sheets for equipment, lines, valves, and instruments.
  • Collaborate with client end-user groups to ensure accurate specifications for equipment and utilities.
  • Draft Technical and Functional Specifications for both automated and manual equipment.
  • Specify requirements for various equipment such as tanks, valves, pumps, fermenters, centrifuges, and chromatography systems.
  • Size and specify utility systems including RODI, PW, WFI, Clean Steam, Plant Steam, Clean Compressed Air, and Waste Systems.
  • Provide engineering expertise and contribute to technical decision-making as an active team member.

Desired Qualifications

  • A Bachelor’s degree or higher in Chemical or Mechanical Engineering.
  • 5-8 years of experience in the Biopharmaceutical sector, ideally in a consulting role.
  • Proven project management experience in an engineering context, preferably within construction.
  • Familiarity with process design and operations, including block flow diagrams and process flow diagrams.
  • Experience in downstream processing techniques such as TFF, microfiltration, ultrafiltration, and purification.
  • Knowledge of Fill/Finish processes.
  • Experience with project startup, walkdowns, as-built P&IDs, FAT, SAT, and commissioning activities.
  • Understanding of clean utilities and associated systems.
  • Comprehensive knowledge of ASME BPE, ISPE, and FDA cGMP standards.
  • Strong verbal and written communication skills.
  • Ability to work autonomously as well as collaboratively within project teams.
  • Relevant industry experience in cGMP drug manufacturing, validation, and chemical process design.
  • Proficient in Microsoft Office and other relevant software tools.

At Hyde Engineering + Consulting, we are dedicated to making a positive impact on health and wellness by ensuring that pharmaceutical and biopharmaceutical manufacturers can produce life-enhancing and life-saving medicines safely and effectively.

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