Process Design Specialist

6 days ago

Toronto, Ontario, Canada Hyde Engineering + Consulting Full time
Job Summary

We are seeking a highly skilled Bioprocess Engineer to join our team at Hyde Engineering + Consulting. As a key member of our team, you will play a critical role in supporting the design phase of new production facilities, including conceptual, basis of design, and detailed design.

Key Responsibilities
  • Design and Specification: Support and lead the design and specification of cGMP equipment, processes, and utilities for biopharma projects.
  • Project Documentation: Create and review project documentation, including URS, FRS, Technical Specifications, and Functional Specifications.
  • Process Modeling: Create and review process models and sizing calculations for process equipment, control valves, and other critical systems.
  • Equipment Management: Manage and populate equipment/line/valve/instrument lists and equipment data sheets.
  • Client Liaison: Liaise with client end-user groups to ensure correct specification of equipment and utilities.
  • Technical Specification: Create Technical Specification and Functional Specification for automated and manual equipment.
  • Utility Systems: Specify requirements for tanks, valves, pumps, fermenters, centrifuges, UF/DF systems, chromatography columns, and other critical systems.
  • Engineering Expertise: Provide engineering expertise and drive technical decisions as an active member of the project team.
Requirements
  • Education: BS degree or higher in chemical or mechanical engineering.
  • Experience: 5-8 years of experience in the Biopharmaceutical industry, preferably in a consulting capacity.
  • Project Management: Must have demonstrated engineering project management experience, ideally in a construction environment.
  • Process Design: Familiarity with process design and operations, including block flow diagrams, process flow diagrams, and other critical systems.
  • Downstream Processing: Experience with downstream processing, including TFF, microfiltration, ultrafiltration, centrifuge, depth filters, harvest, and purification.
  • Fill/Finish: Experience with Fill/Finish operations.
  • Commissioning: Experience with startup, walkdowns, as-built P&IDs, FAT, SAT, and commissioning.
  • Clean Utilities: Experience with clean utilities and drop points, connections, drain, and waste systems.
  • Regulatory Knowledge: Excellent knowledge of ASME BPE, ISPE, and FDA cGMP requirements.
  • Communication Skills: Strong verbal and written communication skills.
  • Teamwork: Ability to work independently and within project teams.
  • Industry Experience: Industry experience related to cGMP drug manufacturing, validation, and chemical process design.
  • Computer Skills: Strong computer knowledge, including Microsoft Office products.

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