Sterilization Engineering Lead — GMP & Continuous Improvement

RXinsider LTD.; Irvine (CA); On-site; USD 126,000 - 157,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. in Irvine is seeking a Sr.

Engineering Specialist to lead sterilization systems within a regulated medical device and pharmaceutical environment. You will serve as SME for terminal steam sterilization and related equipment, partnering with manufacturing, quality, validation and maintenance teams. The role emphasizes troubleshooting, process optimization, validation, and change control, with opportunities to drive efficiency, compliance, and business continuity while

Qualifications

• Bachelor's degree in Chemical, Mechanical, Biomedical, or related Engineering.
• 10+ years of engineering experience in a regulated manufacturing environment.
• Experience supporting sterilization, manufacturing, or process equipment.
• Strong knowledge of GMPs, validation, change control, and engineering documentation practices.
• Demonstrated troubleshooting, project management, and problem-solving skills.
• Strong communication and collaboration skills.

Responsibilities

• Serve as the site SME for sterilization processes and related equipment.
• Support and improve terminal steam sterilization systems and manufacturing operations.
• Troubleshoot equipment and process issues, identify root causes, 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

Troubleshooting

Project management

Problem-solving

Communication

Collaboration

Education

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

Job description

B. Braun Medical Inc. in Irvine is seeking a Sr.

Engineering Specialist to lead sterilization systems within a regulated medical device and pharmaceutical environment. You will serve as SME for terminal steam sterilization and related equipment, partnering with manufacturing, quality, validation and maintenance teams. The role emphasizes troubleshooting, process optimization, validation, and change control, with opportunities to drive efficiency, compliance, and business continuity while