ZipRecruiter
Process Development Engineer (MSAT/Pilot-Scale)
ZipRecruiter, Salt Lake City, Utah, United States, 84193
Job Description
Our client is seeking a
motivated and detail-oriented Engineer
to join their Manufacturing Science and Technology (MSAT) team. This role supports
pilot-scale process execution
and
technology transfer activities
in the MSAT pilot lab, contributing directly to the development and scale-up of processes that bring life-changing therapies to patients. The ideal candidate will thrive in a collaborative, fast-paced environment and will play a key role in executing bioprocess operations, analyzing data, and supporting equipment readiness while maintaining a safe and compliant lab environment. Key Responsibilities Support
cell culture and purification operations
as well as media and buffer preparation for GLP campaigns. Execute pilot-scale experiments, including preparation, set-up, operation, troubleshooting, and cleaning of bioprocess equipment (bioreactors, filtration systems, chromatography systems, buffer/media prep, etc.). Collect, analyze, and document process data, ensuring
accurate and compliant records
(batch records, lab notebooks, and electronic systems). Assist with lab management: inventory control, material handling, and coordination of sample flow. Draft and revise technical documentation, including
SOPs, protocols, reports, and batch records . Prepare technical summaries, reports, and presentations to share findings with cross-functional teams. Collaborate on
technology transfer and scale-up activities , supporting evaluation of process parameters and continuous improvement efforts. Support ad-hoc analytical testing and satellite cell culture for GMP runs when needed. Ensure strict compliance with
GxP, safety protocols, and company quality standards . Major Deliverables High-quality and compliant documentation of process runs. Process data analysis with clear reporting and communication to internal teams. Contributions to
technology transfer packages
and process scale-up activities. Well-maintained lab environment, including equipment records, calibration logs, and troubleshooting documentation. Process improvement recommendations, with updates to SOPs, protocols, or training materials. Qualifications Required: BS in Chemical, Mechanical, Biomedical Engineering, or related discipline. 1–3 years of engineering experience in biotechnology or pharmaceuticals. Hands-on lab experience, with exposure to
bioreactors and downstream operations
(including filtration). Strong documentation and technical writing skills. Effective communicator, detail-oriented, and adaptable to changing priorities. Ability to work occasional weekends and perform physical activities (lifting 25+ lbs, standing for extended periods, gowning, ladder use, PPE compliance). : Experience with protein therapeutics and bioprocessing technologies (e.g.,
ÄKTA Pure, ÄKTA Pilot, TFF, small/mid-scale bioreactors ). Familiarity with Cytiva Unicorn software and analytical systems (e.g., HPLC). Knowledge of FDA cGxP regulations and GxP system implementation.
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motivated and detail-oriented Engineer
to join their Manufacturing Science and Technology (MSAT) team. This role supports
pilot-scale process execution
and
technology transfer activities
in the MSAT pilot lab, contributing directly to the development and scale-up of processes that bring life-changing therapies to patients. The ideal candidate will thrive in a collaborative, fast-paced environment and will play a key role in executing bioprocess operations, analyzing data, and supporting equipment readiness while maintaining a safe and compliant lab environment. Key Responsibilities Support
cell culture and purification operations
as well as media and buffer preparation for GLP campaigns. Execute pilot-scale experiments, including preparation, set-up, operation, troubleshooting, and cleaning of bioprocess equipment (bioreactors, filtration systems, chromatography systems, buffer/media prep, etc.). Collect, analyze, and document process data, ensuring
accurate and compliant records
(batch records, lab notebooks, and electronic systems). Assist with lab management: inventory control, material handling, and coordination of sample flow. Draft and revise technical documentation, including
SOPs, protocols, reports, and batch records . Prepare technical summaries, reports, and presentations to share findings with cross-functional teams. Collaborate on
technology transfer and scale-up activities , supporting evaluation of process parameters and continuous improvement efforts. Support ad-hoc analytical testing and satellite cell culture for GMP runs when needed. Ensure strict compliance with
GxP, safety protocols, and company quality standards . Major Deliverables High-quality and compliant documentation of process runs. Process data analysis with clear reporting and communication to internal teams. Contributions to
technology transfer packages
and process scale-up activities. Well-maintained lab environment, including equipment records, calibration logs, and troubleshooting documentation. Process improvement recommendations, with updates to SOPs, protocols, or training materials. Qualifications Required: BS in Chemical, Mechanical, Biomedical Engineering, or related discipline. 1–3 years of engineering experience in biotechnology or pharmaceuticals. Hands-on lab experience, with exposure to
bioreactors and downstream operations
(including filtration). Strong documentation and technical writing skills. Effective communicator, detail-oriented, and adaptable to changing priorities. Ability to work occasional weekends and perform physical activities (lifting 25+ lbs, standing for extended periods, gowning, ladder use, PPE compliance). : Experience with protein therapeutics and bioprocessing technologies (e.g.,
ÄKTA Pure, ÄKTA Pilot, TFF, small/mid-scale bioreactors ). Familiarity with Cytiva Unicorn software and analytical systems (e.g., HPLC). Knowledge of FDA cGxP regulations and GxP system implementation.
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