Senior Sterilization Engineering SME - Onsite

B. Braun Melsungen AG; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, CA, is seeking a Sr. Engineering Specialist to lead sterilization efforts in a regulated medical device and pharmaceutical environment.

You will partner with Manufacturing, Quality, Validation and Maintenance to optimize equipment performance, support qualification activities, troubleshoot issues and drive continuous improvement while maintaining GMP compliance. Preferred extensive experience in sterilization technologies is valued.

Qualifications

• Bachelor's degree in Chemical, Mechanical, Biomedical, or related Engineering; 10+ years in regulated manufacturing.
• Experience in sterilization, manufacturing or process equipment.
• Strong GMP, validation, change control, and engineering documentation practices.

Responsibilities

• Serve as site SME for sterilization processes and equipment.
• Support terminal steam sterilization systems and manufacturing operations.
• Troubleshoot equipment and process issues and implement sustainable solutions.
• Support commissioning, qualification, validation, and change control activities.
• Lead and support engineering projects focused on reliability, compliance, efficiency, and business continuity.
• Develop and maintain technical documentation, procedures, and engineering records.
• Partner with cross-functional teams to drive operational excellence and continuous improvement initiatives.

Skills

Sterilization processes

GMP compliance

Root cause analysis

Project management

Engineering documentation

Cross-functional collaboration

Education

Bachelor's degree in Chemical, Mechanical, Biomedical, or related Engineering

Job description

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, CA, is seeking a Sr. Engineering Specialist to lead sterilization efforts in a regulated medical device and pharmaceutical environment.

You will partner with Manufacturing, Quality, Validation and Maintenance to optimize equipment performance, support qualification activities, troubleshoot issues and drive continuous improvement while maintaining GMP compliance. Preferred extensive experience in sterilization technologies is valued.