Sterility Assurance Engineering Lead: Strategy & Validation

Lifecore Biomedical; Chaska (MN); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

4 weeks PTO first year

401k with company matching

Health insurance plans

Paid family leave

Job summary

Lifecore Biomedical, LLC in Chaska, Minnesota, is hiring a Sterility Assurance Engineering Manager onsite to lead a cross-functional team and drive validated, compliant sterilization programs across EtO, gamma, and related processes.

You will oversee VMPs, risk-based change control, investigations, and continuous improvement, partnering with quality, engineering, and regulatory teams to ensure product integrity and regulatory readiness.

Qualifications

• Bachelor's degree in Life Sciences or Engineering.
• 8+ years in a medical device/regulated manufacturing environment.
• Experience in quality engineering and process validation activities.
• Aseptic Process Simulation (APS) design and execution; oversight preferred.
• GMP knowledge for medical devices/pharmaceuticals; sterile processes.

Responsibilities

• Lead sterility assurance engineers; mentor and supervise.
• Provide hands-on technical leadership during execution, deviations, and investigations.
• Define sterility assurance vision aligned with regulatory expectations.
• Manage timelines, priorities, and resources across sterility programs.
• Lead development and execution of validation activities (process, equipment, sterilization, facility).
• Oversee VMPs for facilities and critical processes; ensure risk-based changes.

Skills

Sterility assurance

Technical leadership

Project management

Data interpretation

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or Engineering

Job description

Lifecore Biomedical, LLC in Chaska, Minnesota, is hiring a Sterility Assurance Engineering Manager onsite to lead a cross-functional team and drive validated, compliant sterilization programs across EtO, gamma, and related processes.

You will oversee VMPs, risk-based change control, investigations, and continuous improvement, partnering with quality, engineering, and regulatory teams to ensure product integrity and regulatory readiness.