Bioprocess Engineer – Microbial Fermentation & DSP

About the role

The Bioprocess Engineer provides technical leadership for microbial fermentation and downstream processing within a Contract Manufacturing Organization. The role focuses on optimizing production cycles, ensuring compliance, and supporting client interactions.

Key responsibilities

• Serve as subject matter expert for site operations, guiding enzyme fermentation and downstream workflows.
• Operate large‑scale fermentation vessels, chromatography skids, TFF/filtration units, and lyophilization equipment.
• Troubleshoot complex process deviations and equipment malfunctions.
• Assist with calibration, routine servicing, and preventive maintenance of production instrumentation.
• Update SOPs and technical documentation to maintain audit readiness.
• Communicate process data and capabilities to external clients in a CDMO setting.
• Lead site‑wide validation strategy (IQ/OQ/PQ) and design preventive maintenance programs.
• Ensure adherence to cGMP, ISO, company policies, and the site QMS.

Required profile

• Legal authorization to work in the United States.
• Bachelor’s degree in Chemical, Biochemical, Bioengineering, Electrical Engineering or related Life Sciences.
• Minimum 2 years of hands‑on experience in industrial bioprocessing or related manufacturing.
• Proven ability to work in a highly regulated environment with cGMP and ISO compliance.
• Physical capability to handle chemical reagents and biological materials.

Required skills

• Microbial fermentation
• Downstream processing (DSP)
• Large‑scale fermentation operation
• Chromatography
• Tangential flow filtration (TFF)
• Lyophilization
• Process validation (IQ/OQ/PQ)
• Preventive maintenance planning
• Equipment calibration
• cGMP and ISO compliance
• SOP development and documentation