Aseptic Quality Engineer

fairlife, LLC is a Chicago-based nutrition company that creates great-tasting, nutrition-rich dairy products to nourish consumers. With over $3B in annual retail sales, fairlife’s portfolio of delicious, lactose‑free, real‑dairy products includes: fairlife® ultra‑filtered milk;
Core Power® High Protein Shakes, a sports nutrition drink to support post‑workout recovery; fairlife® nutrition plan™, a nutrition shake to support the journey to better health. A wholly owned subsidiary of The Coca‑Cola Company, fairlife, LLC has been recognized by both Fast Company and Nielsen for its industry‑leading innovation.

The Aseptic Quality Engineer will lead efforts across all manufacturing sites to reduce quality failures, improve manufacturing efficiency, and drive quality improvement initiatives. The role will partner with equipment manufacturers to lead failure investigation activities to reduce product hold and deviation occurrences, support validation activities as part of new line extensions and engineering change requests, and collaborate with process authority on validation and regulatory compliance.

• Lead RCA/CAPA process with operational and engineering teams to identify and assign causes to aseptic system failures and create solutions to reduce product holds associated with aseptic system deviations.
• Coordinate and support full line validation efforts with regulatory agencies and 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 requests (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.

• Bachelor’s degree in microbiology, food science, engineering, or a closely related field.
• Experience in a LACF quality assurance manufacturing environment.
• Understanding of equipment design: ability to read a P& familiarity with 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.

• Hybrid schedule; 40–45 hours, as needed.
• Ability to lift up to 50 pounds.
• Travel < 20%.

• Notify supervision of any repairs or adjustments that may affect product quality or food safety.
• Understand, observe, and comply with the handling and usage of the color‑coded container policy while in the Production Areas.
• Perform all duties necessary to meet company, customer, and/or government requirements/standards as prioritized by the company.
• Initiate action to prevent the occurrence of nonconformities relating to food safety and the quality of the product, processes, quality system, or safety system.
• Identify and record any problems relating to food safety and the quality of ingredients, processes, quality system, or safety system.
• Control further processing or delivery of nonconforming product in terms of food safety and quality issues until the deficiency or unsatisfactory condition has been corrected.
• In the event of absence, another employee…