Aseptic Quality Engineer

job purpose: The Aseptic Quality Engineer will efforts across all manufacturing sites to reduce quality failures, improve manufacturing efficiency, and drive quality improvement initiatives. Work with process authority to support validation activities as part of new line extension and engineering change requests. Partner with equipment manufacturers to lead failure investigation activities to reduce product hold and deviation occurrences.    

responsibilities:  

• Lead RCA/CAPA process with operational and engineering teams to identify and assign cause to aseptic system failures and create solutions for reduction in product holds associated with aseptic system deviations  

• Coordinate and support full line validation efforts with regulatory agency/process authority for approval of new line installation and/or line extensions. Serve as liaison between OEM and regulatory agency/process authority as required.  

• Submit engineering change request (ECR) to process authority for all LACF system enhancements and changes. Serve as liaison between process authority and manufacturing sites for coordination of ECR approvals and validation requirements 

• Support “Grade A” extended run requests and approvals. Serve as liaison between regulatory agency and manufacturing sites for request submittal and coordination of extended run trial protocols 

• Support site engineering in equipment design and process improvement efforts to drive quality enhancements, improve operating efficiencies, and ensure compliance against LACF, PMO, and CFR standards.  

skills/qualifications required: 

• Bachelor’s degree in microbiology, food science, engineering or closely related field 

• Experience in a LACF quality assurance manufacturing environment  

• Understanding of equipment design: ability to read a P&ID, understanding of HHST, Aseptic Filling, pump, and critical instrumentation  

• Strong understanding of dairy microbiology  

• High proficiency in computer technology and manufacturing systems operations 

• In-depth understanding of dairy regulatory (PMO/CFR) requirements 

• Strong understanding of RCA tools and ability to work with cross-functional teams to address quality failures 

• Knowledge of continuous improvement methodology and application  

• Excellent verbal and written communication skills 

• Able to work efficiently in a team environment 

• Ability to support regulatory, GFSI, & ISO audits as needed 

• Proficiency in English: Comfortable with both written and verbal communication, including reading and writing. 
   

working conditions and physical requirements: 

• Hybrid 40-45 hours as needed 

• Ability to lift up to 50 pounds 

• Travel <20% 

 

food safety requirements:  

• Notify supervision of any repairs or adjustments that are required that may affect product quality or food safety.