Senior Sterility & Aseptic Validation Engineer - Hybrid

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

Benefits offered by this job

Healthcare plans

HSA with company contributions

Dental & vision insurance

3 weeks PTO

9 company holidays + 2 personal days

Job summary

Lifecore Biomedical, Inc. is seeking a Senior Sterility Assurance Engineer in Chaska, MN. This role focuses on defining and executing aseptic process simulations, validation protocols, and related studies to ensure sterile product quality.

Hybrid work is offered with some on-site requirements for audits and collaboration. Ideal candidates have a BS in engineering or life sciences with 5–8 years in sterility or quality engineering, and experience in aseptic filling and cleaning validation within

Qualifications

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

Responsibilities

• Define, execute, review/approve and summarize aseptic process simulations and validation protocols.
• Conduct smoke studies, cleaning validation, media fills, steam/secondary sterilization activities.
• Perform investigations into failures and provide technical leadership for validations.
• Support audits and provide expertise for quality improvements.

Skills

Sterility Assurance

Project management

Cross-functional collaboration

Education

BS in Engineering or Life Sciences

Tools

Aseptic filling

Cleaning validation

FMEA

Job description

Lifecore Biomedical, Inc. is seeking a Senior Sterility Assurance Engineer in Chaska, MN. This role focuses on defining and executing aseptic process simulations, validation protocols, and related studies to ensure sterile product quality.

Hybrid work is offered with some on-site requirements for audits and collaboration. Ideal candidates have a BS in engineering or life sciences with 5–8 years in sterility or quality engineering, and experience in aseptic filling and cleaning validation within