Lead Advanced Biomanufacture Engineer (Center for Regenerative Biotherapeutics)

Mayo Clinic • Rochester, MN

94d

About The Position

The Work Unit Engineer is responsible for developing, innovating, evaluating, and implementing methodologies, technologies, or products for the laboratory under the intellectual and scientific guidance of CRM management. This role involves preparing for and executing manufacturing batch records, work instructions, and/or SOPs. The engineer must maintain up-to-date training records and documentation of all activities to meet cGMP requirements and ensure compliance in assigned work. Additionally, participation in other required activities such as performing safety inspections and engaging in improvement projects is expected.

Requirements

• Bachelor's degree and 10 years of relevant industry/academia experience, or a Master's degree in bioengineering, engineering, biological science, chemistry, immunology, cell/molecular biology, or other related science with 5-7 years of relevant experience.
• 5-7 years of manufacturing experience.
• cGMP clean room experience required.
• Experience in process development and process characterization of scale-up/scale-down cell manufacturing processes.
• Strong decision-making skills and ability to work independently.
• Excellent written and verbal communication skills.
• Demonstrated analytical and scientific competency with process development and/or validation of lab techniques or procedures.
• Experience with data collection, organization, analysis, and delivery of information.

Nice To Haves

• Strong leadership skills.
• Deep understanding of cGMP standards.
• Experience with aseptic technique in cleanroom manufacturing.

Responsibilities

• Develop, innovate, evaluate, and implement methodologies, technologies, or products for the laboratory.
• Prepare and execute manufacturing batch records, work instructions, and/or SOPs.
• Maintain up-to-date training records and documentation to meet cGMP requirements.
• Ensure cGMP compliance in assigned work.
• Participate in safety inspections and improvement projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Hospitals
• Education Level: Master's degree