Process Engineer
The Process Engineer will be part of BioMADE’s Hayward pilot plant operations team. This pilot plant will help bridge a gap in the domestic biotech industry (non-pharma), providing clients with emerging fermentation technologies the ability to demonstrate upstream and downstream processes at a scale which supports future commercial scale design. The Process Engineer is responsible for translating customer fermentation and downstream process requirements into operational procedures, batch documentation, and technical guidance that enable the Operations team to successfully execute production campaigns.
Working closely with the Projects Lead, Operations Manager, Shift Supervisors, and Technical Laboratory Manager, the Process Engineer serves as the primary technical interface between customers and production facility operations during process technology transfer, campaign preparation, production execution, and post-production technology transfer closure.
The role requires strong knowledge of fermentation processes and downstream processing unit operations, with particular emphasis on downstream separations and purification systems. The Process Engineer will actively promote and exemplify a “zero harm” safety culture.
Working closely with the Projects Lead, Operations Manager, Shift Supervisors, and Technical Laboratory Manager, the Process Engineer serves as the primary technical interface between customers and production facility operations during process technology transfer, campaign preparation, production execution, and post-production technology transfer closure.
The role requires strong knowledge of fermentation processes and downstream processing unit operations, with particular emphasis on downstream separations and purification systems. The Process Engineer will actively promote and exemplify a “zero harm” safety culture.
Note: This position is offered at two levels: Process Engineer or Sr. Process Engineer, allowing candidates to apply based on their experience and qualifications. The total compensation range for this position is $120,000 - $150,000. Many factors are taken into consideration when determining compensation, such as possessing the Required Qualifications, Preferred Qualifications, level of education and experience, with consideration given to internal equity.
Technology Transfer and Process Implementation
Technology Transfer and Process Implementation
- Work with Projects Lead to translate client technology transfer packages into executable production processes.
- Understand, communicate, and convert client process expectations into: batch records, batch recipes, operating procedures, process control parameters, process flow summaries, and operational guidance including operator training documents
- Ensure process documentation and training positions the Operations team to execute production campaigns safely and effectively.
- At the conclusion of client campaigns, prepare process summary reports and data packages for client representatives to include items such as: fermentation performance (titer, rate, yield) against expectations, downstream unit operation performance (to include yields), analytical results. Process deviations should be summarized for the client.
Bench-Scale Trials and Process Validation
- With the Technical Lab Manager, support planning and assessment of laboratory trials as required using bench-scale fermentation and downstream equipment to:
- Demonstrate the viability of client technology transfer packages
- Identify and close potential gaps prior to running the process at pilot scale.
- This may include generating data related to: fermentation performance, downstream separation performance, product recovery yields
Operations Support
- Serve as primary technical expert for process unit operations, training shift supervisors and operations team on fundamental principles of operation, modes of operation, programming sequences, equipment safeguards, alarms (purpose and response), and troubleshooting.
- At the direction of the Operations Manager, prepare standard operating procedures, troubleshooting guides, and other reference documents that provide a foundation for consistent operation and understanding.
- Collaborate with shift supervisors and process operators to address process observations, concerns, and recommendations. Use these to develop and execute action plans.
- Foster an environment of open communication and continuous improvement.
- Utilize plant process data as well as in process analytical data to create dash boards and metrics that the Operations Manager deems to provide value for team performance.
- Work with Operations Manager and Maintenance Manager to provide troubleshooting support for fermentation and downstream equipment, recommending corrective action and improvements as needed.
- May provide hands-on operational support during critical campaigns, startup activities, commissioning efforts, or periods of limited staffing.
Safety Leadership
- Actively support the facility’s “zero harm” safety culture by:
- Leading by example
- Ensuring process procedures include safety considerations
- Work with the team to identify and address potential hazards in fermentation and downstream operations
- Engaging plant personnel in proactive safety discussions
Required
- Bachelor’s degree in one of the following fields: Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, or other related discipline.
- 5 years experience as process engineer in fermentation or bioprocess development or manufacturing environments.
- Experience in technology transfer, scale-up methodologies, process development, or production support (commercial or CDMO scale)
- Sound knowledge of Fermentation fundamentals and downstream separation technologies
- Experience in Data analysis systems, process monitoring, and process troubleshooting acumen
- Strong safety mindset with demonstrated commitment to safe work practices
- Demonstrated ability to effectively communicate technical concepts to operations, laboratory, maintenance personnel, and customers/clients. Ability to translate complex processes into operational procedures and guidelines.
- Comfortability to lead Client interactions and project coordination.
Preferred
- Master’s degree in one of the following fields: Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, or other related discipline.
- 8 or more years experience as process engineer in fermentation or bioprocess development or manufacturing environments.
- Downstream expertise preferred with unit operations such as: centrifuges (disc stack, decanter), ultrafiltration, microfiltration, ion exchange, evaporators, spray dryers, and homogenizers.
- Prior experience within CDMO environment (preferably with food-safe quality standards), bench-to-pilot scale up, pilot-to-commercial scale up.
- Experience writing and modifying fermentation scripts and recipes utilizing a variety of programming methodologies and languages
- Experience with Factory Talk and/or Ignition automation and programming environments
BioMADE provides a comprehensive suite of health insurances, supplemental benefits, and paid time off to all regular full-time employees as outlined below. Additional benefits include:
100% employer-paid options for medical, dental, and vision
- Paid time off that accrues from your hire date
- 13 paid holidays, including a winter closure between Christmas Eve and New Year’s Day
- Hybrid work policy for most positions; stipend for internet and personal phone use
- 401(k) retirement plan with up to 6% match on compensation (no vesting period!)
Discretionary Incentive Plan based on organizational and individual performance - 100% employer-paid short-term disability and life insurance
- Paid parental leave
- Section 125 Flexible Spending Plan for medical and dependent care
- Commuter pre-tax benefit
- Full access to LinkedIn Learning’s suite for professional development
- Free parking, casual dress code, free snacks and beverages, and on-site gym access at both offices
- Fun on and off-site employee activities sponsored by the Employee Engagement Committee
- And much more
We nurture merit, talent, and achievement by supporting equal opportunity and welcome people of all backgrounds and beliefs to join us in our mission to enable domestic bioindustrial manufacturing at all scales. Come join our team!