BlueNalu, Inc. is a rapidly growing, San Diego-based company that is pioneering the production of seafood products derived directly from fish cells. Using proprietary cell biology techniques and engineering processes, BlueNalu’s platform technology can produce a wide array of value-added seafood products, that are healthy for people, humane for sea life, and sustainable for our planet. Our products will be great tasting, trusted, safe, and free of mercury and environmental contaminants. BlueNalu has achieved considerable strategic, technical, and operational milestones since its formation and it is now preparing for regulatory clearance and market launch in the US.

Job Summary

As the Principal Bioprocess Plant Engineer, you will be responsible for supporting the Operations and Process Engineering groups in equipment design, procurement, installation, and ownership. You will be a key contributor to the design, scale-up, technology transfer, and operation of cell culture processes at large scale. The ideal candidate is a demonstrated industry expert in all engineering aspects of cell culture production. The breadth of this role spans Development to Operations and requires demonstrated experience in both Process Engineering and Plant Engineering settings. This role will be a vital member of the Process Engineering and Operations teams and reports to the Vice President of Operations. For the selected candidate, this role provides an opportunity to be a key player in bringing about a fundamental change in the evolution of food supply.

Essential Responsibilities

• Subject Matter Expert (SME) and system owner for core bioprocess equipment in current state-of-art pilot- and large-scale cell culture processes and cell recovery systems
• Lead procurement of bioprocess equipment and necessary utility systems, including generation of URS and design specifications
• Cell culture science process expert to partner closely with bench scientist/engineers in process design, scale-up, technology transfer, process implementation, and operator training
• Lead critical aspects of cell-culture scale up including but not limited to equipment and process design, fluid dynamics analysis, mass/heat transfer analysis, and process modeling
• Lead/assist with critical aspects of process equipment start up including installation, commissioning, qualification, development testing, and troubleshooting
• Assist with establishing operational infrastructure required for success, such as training, documentation, and supplies
• Participate and serve as SME in key discussions on design and construction of manufacturing facilities
• Continuously build network of industry SMEs and key collaborators
• Interfaces and leads projects with external contractors/vendors
• Drive Reliability and Continuous Improvement Projects for Operations
• Uses appropriate tools for required work to track, document, report data and manage key capital projects
• Collects, reviews, enters, and formats accurate data into spreadsheets, databases, and other electronic tools
• Work seamlessly within and across functions for transparent, efficient, and successful collaborations
• Communicates and keeps stakeholders informed on the project status of work completion and possible risks relative to scheduled deadlines and milestones.

Job Supervised (by title):

• Vice President of Operations

Travel: Estimates at 10%

Minimum Qualifications & Experience

A. Education and Experience:

• Bachelor’s Degree in Chemical Engineering or related field
• Minimum 10 years of relevant work experience in biopharmaceutical process engineering, plant engineering, and GMP manufacturing

B. Knowledge, Skills and Abilities:

• Must be highly skilled in bioprocess equipment operation and associated cell culture techniques, downstream processing techniques for cell recovery, control system configuration, data acquisition, and maintenance
• Sought after cell culture industry expert in successful process scale-up, implementation, and operation
• Technically sound bioprocess engineering fundamentals
• Excellent communication (verbal and written) and organizational skills
• Balance of tactical execution and strategic mindset
• Full understanding of bioprocess manufacturing and laboratory safety regulations
• Collaborative, both vertically within diverse teams and horizontally throughout the organization
• Hands-on experience and mechanical aptitude for troubleshooting and maintaining bioreactor hardware and control systems
• Demonstrated ability to conceive, plan and execute engineering projects and operations
• Demonstrated experience in leading or participating in design and procurement of capital process equipment
• Working knowledge of protocols and operations in GMP environment

Nonessential Qualifications

• Experience with bioprocess manufacturing facility and utilities
• Experience with bioprocess manufacturing IT, control systems (PCS, historian, MES)
• Professional Engineer certification or equivalent
• Experience creating and managing drawings in CAD

Materials and Equipment Directly Used

• Microsoft Office Suite and other computer systems

Working Environment / Physical Demands

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands:

• Ability to lift 20 pounds

Work Environment:

• Must understand vague and implicit instructions and react favorably in all work situations
• Must be mentally adaptable and flexible in dealing with a variety of people
• Emotional stability and personal maturity are important attributes in this position
• Must be able to resolve problems, handle conflict and make decisions under pressure
• Ability to give, to receive, and analyze information, formulate work plans and prepare written materials and articulate goals and action plans
• Must understand people and be able to communicate effectively
• Ability to work with and directly handle products containing Major US Allergens and sensitizing agents such as fish, soy, and shellfish