Bioprocess Engineer

Microbial Fermentation Technical Leader

Provides technical leadership in microbial fermentation and bioprocess operations. This role involves a specialized focus on optimizing microbial fermentation and managing critical downstream process operations in a Contract Manufacturing Organization (CMO) environment.

Essential functions, included but not limited to:

• Provide technical subject matter expertise to support various site operations and ensure seamless production cycles.
• Collaborate cross-functionally to refine and optimize enzyme fermentation and downstream processing workflows to improve yield and scalability.
• Hands-on operation of core bioprocessing systems, including large-scale fermentation vessels, chromatography skids, TFF/filtration units, and lyophilization equipment.
• Act as the primary technical resource for resolving complex process deviations and equipment malfunctions.
• Assist with the calibration and routine servicing of precision production instrumentation.
• Assist in the revision of Standard Operation Procedures (SOPs) and technical documentation to maintain high quality standards and audit readiness.
• Serve as the primary technical point of contact for external clients, effectively communicating process data, technical decision-making, and site-specific capabilities in a Contract Development and Manufacturing Organization (CDMO) setting.
• Define and lead the site-wide strategy for process and equipment validation (IQ/OQ/PQ), ensuring all systems meet rigorous operational standards.
• Design and implement PM programs for critical bioprocessing hardware to minimize downtime and extend equipment lifecycle.
• Ensure all activities strictly adhere to Company policies, cGMP guidelines, internal Standard Operating Procedures (SOPs), and the site's Quality Management System (QMS).

Other functions:

• Ensure compliance with safety regulations and procedures are implemented and followed; maintain clean and safe work area.
• Assist as needed in other areas of the company where training requirements have been completed.
• Perform other duties as assigned.

Supervisory responsibilities: None.

Travel: None.

Requirements:

Required qualifications:

• Legally authorized to work in the United States.
• Bachelor of Science degree in an Engineering discipline (Chemical, Biochemical, Bioengineering, or Electrical) or a related Life Sciences field (Biotechnology, Biology, Chemistry).
• At least 2 years of hands-on experience in industrial bioprocessing or a related manufacturing field, with a proven track record of supporting production-scale operations.
• Demonstrated ability to operate within a highly regulated environment, ensuring all engineering activities maintain strict adherence to cGMP and ISO compliance requirements.
• Physically and technically capable of working with a variety of chemical reagents and biological materials (e.g., microbial cultures, enzymes) required for fermentation and downstream processing.
• Flexibility to work some limited off-shift and weekend hours in order to support all production shifts when needed.
• Strong mechanical aptitude with the ability to diagnose, disassemble, and repair complex bioprocessing hardware and fluid-handling systems.

Preferred qualifications:

• Functional understanding of automated bioprocessing platforms; able to navigate HMI (Human Machine Interface) software to monitor, control, and optimize fermentation and DSP sequences.
• Industrial plant experience with a specific focus on process scale-up, troubleshooting, and continuous improvement (CI) initiatives.

Basic skills and abilities:

• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Ability to work independently and as a member of various teams and committees.
• Detail oriented with a high level of accuracy, efficiency, and accountability.
• Strong organizational skills to meet goals and set priorities.
• Proactively identify problems and develop solutions to improve manufacturing operations and safety.
• Participate in cost-saving initiatives and maintain or improve product quality and yield.
• Proficient in MS Office Suite.
• Ability to operate related office equipment, such as computer, calculator, and copier.

Reasoning abilities:

• Ability to apply logic and common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Language skills:

• Ability to read and interpret work related documents, procedures, and manuals.
• Ability to communicate effectively; good written and oral communication skills; ability to read, write, speak, and understand the English language.
• Good interpersonal skills such as ability to communicate effectively, internally, and externally at all levels and diverse personalities.

Mathematical skills:

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents.

Visual acuity:

• Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.

Physical demands:

• Must be able to wear and work in personnel protective equipment (PPE) as required.
• Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
• Stationary position sitting for prolonged periods of time while utilizing standard office tools.
• Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper.
• The ability to hear, understand, and distinguish speech.
• Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations.
• Frequently lift and/or move up to 50 pounds.
• Frequently reaching for items above and below desk level.
• Occasionally required to climb or balance; squat, stoop, kneel, or crouch.

Environment conditions:

• Well, lit, heated/air-conditioned indoor office setting with adequate ventilation.
• The noise level in the work environment is moderate.
• Periodic exposure to low temperatures in controlled refrigerators and/or freezers.
• Periodic exposure to high temperatures may occur when working with specific pieces of equipment.
• Some exposure to hazards or physical risks which require following basic safety precautions.