Bioprocess Engineer

2 days ago

Toronto, Ontario, Canada Hyde Engineering + Consulting Full time
Job Title: Bioprocess Specialist

Hyde Engineering + Consulting is seeking a highly skilled Bioprocess Specialist to support the design phase of new production facilities for the biopharmaceutical industry.

Key Responsibilities:
  • Support the design and specification of cGMP equipment, processes, and utilities for biopharma projects.
  • Create and review project documentation, including URS, FRS, Technical Specifications, and Functional Specifications.
  • Develop and review process models and sizing calculations for process equipment, control valves, and other critical systems.
  • Manage and populate equipment lists, data sheets, and other project-related documentation.
  • Liaise with client end-user groups to ensure correct specification of equipment and utilities.
  • Develop Technical Specifications and Functional Specifications for automated and manual equipment.
  • Specify requirements for tanks, valves, pumps, fermenters, centrifuges, UF/DF systems, chromatography columns, and other critical equipment.
  • Sizing and specification of utility systems, including clean and plant utilities, RODI, PW, WFI, Clean Steam, Plant Steam, Clean Compressed Air, Other Process Gases, and Waste Systems.
  • Provide engineering expertise and drive technical decisions as an active member of the project team.
Requirements:
  • BS degree or higher in chemical or mechanical engineering.
  • 5-8 years of experience in the Biopharmaceutical industry, preferably in a consulting capacity.
  • Demonstrated engineering project management experience, ideally in a construction environment.
  • Familiarity with process design and operations, including block flow diagrams, process flow diagrams, and other critical systems.
  • Experience with downstream processing, including TFF, microfiltration, ultrafiltration, centrifuge, depth filters, harvest, purification, and other critical processes.
  • Experience with Fill/Finish, startup, walkdowns, as-built P&IDs, FAT, SAT, and commissioning.
  • Excellent knowledge of ASME BPE, ISPE, and FDA cGMP requirements.
  • Strong verbal and written communication skills.
  • Ability to work independently and within project teams.
  • Industry experience related to cGMP drug manufacturing, validation, and chemical process design.
  • Strong computer knowledge, including Microsoft Office products.

Hyde Engineering + Consulting is an equal opportunity, affirmative action employer. We contribute to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To learn more about our culture and benefits, visit our website.

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