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 Hyde is an equal opportunity, affirmative action employer. Associate #J-18808-Ljbffr