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.