Process Development Engineer (MSAT/Pilot-Scale)

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.