Aseptic Quality Engineer

fairlife•Coopersville, MI

1d•$90,000 - $115,000•Hybrid

About The Position

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.

Requirements

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.

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.

Benefits

Comprehensive medical, dental, and vision coverage, effective day one!
Supplemental health plans (hospital indemnity, accident, and critical illness insurance)
Paid Time Off to recharge and support work-life balance
Paid parental leave & adoption assistance (up to $10,000)
Parental support & family care benefits, including childcare resources and lactation support
401(k) to support retirement planning with up to 9% in employer match
Wellness reimbursement (up to $500 for qualified wellbeing expenses)
Employee Assistance Program (EAP) for emotional wellbeing and work-life support
Company-paid life insurance and short-term disability
Employer HSA funding (for HDHP participants)
Tuition reimbursement (up to $10,000) and student loan repayment ($200/month)
Learning & development programs to unlock your full potential
Rewards & recognition, matching gifts, free product, and Business Resource Groups