Senior Technical Operations Engineer – Reagent Manufacturing

Position Summary:  

The Bio-Techne Minneapolis site is the company’s largest Reagent Operations Capability Center and Focused Factory, manufacturing and shipping recombinant proteins, antibodies, ELISA kits, Luminex assays, cell culture media, protein analysis instrument reagents, and other products used in academic research, biopharma drug discovery, quality control, and related applications. 

The Senior Process Engineer – Reagent Manufacturing strengthens the site’s manufacturing technical capability by building process understanding, resolving prioritized technical gaps, and improving the robustness, repeatability, quality, and manufacturability of existing processes. 

The role serves as the technical subject matter expert for reagent preparation, liquid handling and transfer, mixing, formulation, and filtration. The engineer evaluates how materials, equipment, scale, process parameters, and operating methods work together to determine overall process capability. This includes evaluating cleanability and recommending process and equipment practices that support appropriate bioburden control. 

The role also provides process-engineering support for cell culture, purification, and other manufacturing processes, partnering with area technical experts when specialized process knowledge is required. 

The engineer leads technical assessments and engineering studies, defines process and equipment requirements, and recommends sustainable improvements. The role also supports manufacturing readiness when products, processes, equipment, or scale are introduced or changed and may be deployed to major process-engineering issues across Minneapolis manufacturing operations. Manufacturing owns routine execution, and Quality retains approval authority. 
Key Responsibilities:  

Process Engineering and Technical Support 

• Lead process-engineering support for prioritized technical gaps within current manufacturing processes.  
• Evaluate overall process capability by assessing materials, equipment, scale, process parameters, operating methods, sources of variation, and process outputs.  
• Build deeper process understanding and recommend improvements that increase robustness, repeatability, quality, and manufacturability.  
• Serve as the technical subject matter expert for reagent preparation, liquid handling and transfer, mixing, formulation, and filtration.  
• Apply process-engineering principles to mixing scale-up, including equipment selection, operating ranges, and confirmation of expected process performance.  
• Evaluate filtration requirements, including filter selection, sizing, operating conditions, compatibility, capacity, and expected process performance.  
• Assess process and equipment cleanability and recommend controls that support appropriate bioburden control.  
• Lead technical assessments of manufacturing issues, determine likely causes, define appropriate engineering studies, and recommend sustainable corrective actions or improvements.  
• Apply process-engineering methods to cell culture, purification, and other manufacturing processes, partnering with area technical experts as appropriate.  
• Identify additional process-improvement opportunities through process observation, technical analysis, and manufacturing experience.  

Equipment and Process Integration 

• Evaluate the suitability of existing equipment for current and changing manufacturing needs.  
• Define process and user requirements and support the selection, sizing, or improvement of equipment used in major manufacturing unit operations.  
• Participate in vendor reviews and testing, commissioning, and qualification activities to confirm that equipment meets defined process requirements.  
• Troubleshoot equipment and process interactions when equipment performance affects process reliability, product quality, or manufacturing execution.  
• Partner with Facilities, Manufacturing Engineering, Automation, and equipment suppliers to convert process needs into practical equipment solutions.  

Process Readiness and Implementation Support 

• Assess process, equipment, scale, and facility readiness when products, processes, or equipment are introduced or changed.  
• Review available product and process knowledge with R&D, development teams, and process owners to identify technical gaps, assumptions, and risks.  
• Translate available process knowledge into clear manufacturing requirements.  
• Define engineering studies and acceptance criteria, analyze results, and provide technical readiness recommendations.  
• Support implementation activities when additional technical evaluation is needed to confirm manufacturing readiness.  

Cross-Functional Partnership 

• Work closely with R&D, Manufacturing, Quality, Facilities, Manufacturing Engineering, Automation, and other site functions to resolve technical gaps and implement sustainable improvements.  
• Lead the technical work while partnering with Manufacturing teams responsible for process execution.  
• Clearly communicate technical risks, study results, and recommendations to manufacturing and site leadership.  
• Capture the technical basis, study results, process requirements, and recommendations needed to support implementation and maintain process knowledge. 

QUALIFICATIONS 

Education and Experience: 

• Bachelor’s degree in engineering required; chemical or biochemical engineering preferred. 
• At least 3 years of relevant process-engineering experience in pharmaceutical, biopharmaceutical, biotechnology, reagent, or diagnostic manufacturing; 5+ years preferred. 
• Demonstrated experience with liquid-processing unit operations, including mixing, formulation, filtration, liquid handling, or liquid transfer. 
• Experience supporting equipment selection, process requirements, commissioning, qualification, or equipment-related troubleshooting. 
• Experience working within a regulated or controlled quality system is preferred but not required. 
• Experience supporting the introduction or significant modification of manufacturing processes or equipment is preferred. 
• Exposure to cell culture, purification, or other biological manufacturing processes is preferred but not required. 

Knowledge, Skills, and Abilities: 

• Strong understanding of process-engineering principles related to liquid handling, mixing, scale-up, formulation, filtration, and equipment selection. 
• Ability to evaluate overall process capability and understand how materials, equipment, process parameters, operating methods, and sources of variation affect manufacturing results. 
• Working knowledge of cleanable processing and process and equipment practices that support appropriate bioburden control. 
• Ability to define engineering studies and acceptance criteria, analyze results, and develop clear technical conclusions and recommendations. 
• Ability to translate tech transfer process needs into equipment and operating requirements. 
• Strong structured problem-solving and root-cause-analysis skills. 
• Ability to lead technical work through Manufacturing teams without owning routine production execution. 
• Ability to apply core process-engineering principles across different manufacturing processes and work effectively with specialized area experts. 
• Strong written and verbal communication skills, including the ability to explain technical issues, risks, and recommendations clearly. 
• Ability to work effectively across R&D, Manufacturing, Quality, Engineering, Facilities, and other site functions. 
• Ability to work within established quality, documentation, and approval systems. 
• Ability to manage multiple priorities and exercise sound technical judgment with limited direction. 

Working Conditions: 

• This is an onsite position supporting office, laboratory, and manufacturing activities at the Minneapolis site. 
• Work may occur in controlled laboratory and manufacturing environments requiring appropriate personal protective equipment and gowning. 
• The position may involve exposure to biological materials, chemicals, mechanical equipment, and other conditions normally present in life-science manufacturing environments. Established safety procedures and controls must be followed. 

Physical Requirements: 

• Ability to move throughout office, laboratory, and manufacturing areas and spend periods of time standing, walking, and observing manufacturing processes. 
• Ability to sit and perform computer-based work for extended periods. 
• Ability to occasionally bend, reach, stoop, and access manufacturing equipment for process observation and assessment. 
• Ability to wear required personal protective equipment and comply with applicable gowning requirements.