Aseptic Quality Engineer
fairlife LLC
Coopersville, MI (In Person)
Full-Time
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Job Description
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:
LeadRCA/CAPA
process with operational and engineering teams toidentifyand assign cause to aseptic system failures andcreate solutions forreduction 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 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 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 operatingefficiencies, and ensure complianceagainstLACF, PMO, and CFR standards.skills/qualifications required:
Bachelor'sdegreein microbiology, food science,engineeringor closely related field Experience inaLACFquality assurancemanufacturingenvironment Understanding of equipment design: ability to read a P&ID, understanding of HHST, Aseptic Filling, pump, and critical instrumentation Strong understanding of dairy microbiology Highproficiencyin computer technology andmanufacturingsystems operations In-depth understanding ofdairy regulatory (PMO/CFR) requirements Strongunderstanding of RCA tools and ability to work with cross-functional teams to address quality failures Knowledge of continuous improvementmethodologyand application Excellent verbal and written communication skills Able to work efficiently in a team environment Ability to support regulatory, GFSI, & ISO audits as neededProficiencyin English:
Comfortable with both written and verbal communication, including reading and writing.workingconditions and physical requirements:
Hybrid40-45 hoursas needed Ability tolift upto 50 pounds TravelSimilar remote jobs
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