Senior Aseptic Process Validation Engineer - Hybrid

Lifecore Biomedical; Chaska (MN); Hybrid; USD 95,000 - 110,000; Full time

Benefits offered by this job

Hybrid schedule

Promotion opportunities

Competitive total rewards package

Wellness and health plans

Job summary

Lifecore Biomedical is seeking a Senior Sterility Assurance Engineer in Minnesota. The role involves defining and executing aseptic process simulations, cleaning validation, smoke studies, and secondary sterilization activities.

You will investigate failures and ensure validated processes remain robust, with leadership in validations and audits. The position offers a hybrid work schedule with on-site needs for meetings and audits.

Qualifications

• BS in Engineering or Life Sciences required.
• 5-8 years of Sterility Assurance or Quality Engineering experience.
• Experience with aseptic filling and cleaning validation.
• Background in pharmaceutical/biotechnology and/or chemistry production is a plus.

Responsibilities

• Define, execute, review/approve and summarize Aseptic Process Simulations, Cleaning Validation, Smoke Studies, Secondary Sterilization activities, etc.
• Investigations into failures and root cause analysis.
• Monitor, support, and review changes to existing validated aseptic processes.
• Provide knowledge leadership and technical expertise for validations and investigations, and support audits.

Skills

Sterility Assurance

Quality Engineering

Aseptic Filling

Cleaning Validation

FMEA

Education

BS in Engineering or Life Sciences

Job description

Lifecore Biomedical is seeking a Senior Sterility Assurance Engineer in Minnesota. The role involves defining and executing aseptic process simulations, cleaning validation, smoke studies, and secondary sterilization activities.

You will investigate failures and ensure validated processes remain robust, with leadership in validations and audits. The position offers a hybrid work schedule with on-site needs for meetings and audits.