Bioprocess Specialist

The Process Engineer would support the design phase (conceptual, basis of design, detailed design) of a new production facility. This includes supporting FAT’s off-site, construction, SAT’s, commissioning, and field engineering for the final phases of the project.

Responsibilities

• Support / lead the design and specification of cGMP equipment, processes and utilities for biopharma projects.
• Create and review project documentation (URS, FRS, Technical Specifications, Functional Specifications)
• Create and review process models and sizing calculations for process equipment, control valves etc
• Manage and populate equipment/line/valve/instrument lists and equipment data sheets
• Liaise with client end user groups to ensure correct specification of equipment and utilities
• Create Technical Specification and Functional Specification for automated and manual equipment
• Specify requirements for tanks, valves, pumps, fermenters, centrifuges, UF/DF systems, chromatography columns
• Sizing and specification of utility systems (clean and plant); RODI, PW, WFI, Clean Steam, Plant Steam, Clean Compressed Air, Other Process Gases, & Waste Systems.
• Provide engineering expertise and drive technical decisions as active member

Desired Skills and Experience

• BS degree or higher in chemical or mechanical engineering
• 5-8 experience in the Biopharmaceutical industry, preferably in a consulting capacity
• Must have demonstrated engineering project management experience ideally in a construction environment
• Familiarity with process design and operations (block flow diagrams, process flow diagrams, etc…)
• Experience with downstream processing experience (TFF, microfiltration, ultrafiltration, centrifuge, depth filters, harvest, purification)
• Experience with Fill/Finish
• Experience with startup, walkdowns, as-built P&IDs, FAT, SAT and commissioning
• Experience with clean utilities and drop points, connections, drain and waste systems
• 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

Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes 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 read more about Hyde's culture and benefits, visit our website: www.hyde-ec.com