Yufei H.
Pharmaceutical Production Process Engineer, P.ENG
- Role
- Senior Process Engineer at Catalent
- Location
- Columbia, MD, US
- LinkedIn followers
- 500 followers
About Yufei H.
Through studying and working experience in the field of process engineering, I gained…
Experience
Senior Process Engineer
Mar 2025 — Present
Analyze and develop engineering solutions to maintenance, continuous improvement, quality and safety initiatives, reliability, and failure investigations for manufacturing equipment/systems, instrumentation, and filling equipment.• Work independently on assigned projects and collaboratively in a multi-functional team environment supporting day-to-day manufacturing schedules and operations.• Hands-on work troubleshooting and repairing bioprocess equipment. Equipment includes fermenters, bioreactors, centrifuges, chromatography systems, incubators, BSCs, controlled temperature units, fillers, isolators analytical and laboratory equipment.• Hands-on work with Fill/finish process scale-up and technology transfer including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)• Work within Computerized Maintenance Management Systems.• Work closely with validation engineers to support equipment commissioning and qualification.• Work with subcontractors as needed on equipment preventive maintenance and repairs.• Assist in maintaining PM programs for the bioprocess equipment and instrumentation. This includes generating PM SOPs/records, establishing PM frequencies, specifying spare parts and recommending/maintaining inventory levels.• Work with equipment vendors and Catalent’s purchasing department to quote/purchase/procure equipment parts and instrumentation.• Initiate/complete various types of GMP documentation such as change control, deviations, corrective and preventive actions (CAPAs), documentation revision.• Accurately maintain/complete all equipment logbooks and maintenance records within the CMMS.• Assist in training of mechanics and manufacturing personnel on the various pieces of bioprocess equipment throughout the facility.• Lead other engineers through daily task and longer term projects.• Develop equipment, instrument, and controls specifications.
Education
University of New Brunswick
Bachelor of Science
2008 — 2015
University of New Brunswick
Bachelor of Engineering (B.Eng.), Chemical Engineering
2008 — 2015
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