Aseptic Quality Engineer

fairlife, LLC is a Chicago-based nutrition company that creates great-tasting, nutrition-rich and 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.

To learn more about fairlife and its complete line of products, please visit fairlife.com.

job purpose:

The Aseptic Quality Engineerwillefforts 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.

Partnerwith equipment manufacturers to lead failure investigation activities to reduce product hold and deviation occurrences.

responsibilities:

Lead

RCA/CAPA

process with operational and engineering teams toidentifyand assign cause to aseptic system failures andcreate solutions forreduction in product holds associated with aseptic system deviationsCoordinate and support full line validation efforts with regulatory agency/process authority for approval of new line installation and/or line extensions. Serve asliaisonbetween OEM and regulatory agency/process authority asrequired.

Submitengineeringchange 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 requirementsSupport "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 protocolsSupport site engineering in equipment design and process improvement efforts to drive quality enhancements, improve operatingefficiencies, and ensure complianceagainstLACF, PMO, and CFR standards.

skills/qualifications required:

Bachelor'sdegreein microbiology, food science,engineeringor closely related fieldExperience inaLACFquality assurancemanufacturingenvironmentUnderstanding of equipment design: ability to read a P&ID, understanding of HHST, Aseptic Filling, pump, and critical instrumentationStrong understanding of dairy microbiologyHighproficiencyin computer technology andmanufacturingsystems operationsIn-depth understanding ofdairy regulatory (PMO/CFR) requirementsStrongunderstanding of RCA tools and ability to work with cross-functional teams to address quality failuresKnowledge of continuous improvementmethodologyand applicationExcellent verbal and written communication skillsAble to work efficiently in a team environmentAbility to support regulatory, GFSI, & ISO audits as needed

Proficiencyin English:

Comfortable with both written and verbal communication, including reading and writing.

workingconditions and physical requirements:

Hybrid40-45 hoursas neededAbility tolift upto 50 poundsTravel