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Process Development Engineer (MSAT / Pilot-Scale)

Process Development Engineer (MSAT / Pilot-Scale)

Redbock - an NES Fircroft companySalt Lake City, UT, United States
3 hours ago
Job type
  • Full-time
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).
  • Preferred :

  • 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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