Sr Engineering Specialist

Company: B. Braun US Pharmaceutical Manufacturing LLC

Job Posting Location: Irvine, California, United States

Functional Area: Other Areas

Working Model: Onsite

Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday

Shift: 5X8

Relocation Available: No

Requisition ID: 13963

Position Summary

The Sr. Engineering Specialist serves as a technical leader supporting sterilization systems, manufacturing equipment, and engineering initiatives within a regulated medical device and pharmaceutical environment.

This position supports the Sterilization Engineering team and will be a SME for Sterilization processes in the plant. Mainly, Terminal Steam sterilization processes and equipment's. Experience with Aseptic processing, VHP decontamination, E-Beam, Sterile filtration processes is a plus.

In this role, you will partner with Manufacturing, Quality, Validation, and Maintenance teams to optimize equipment performance, support validation activities, troubleshoot technical issues, and drive continuous improvement while maintaining compliance with GMP requirements.

In This Role, You Will Have the Chance To:

• Serve as the site Subject Matter Expert (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.

Essential Requirements

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

Preferred Experience Includes

• Terminal Steam Sterilization process and equipment expertise.
• Experience with aseptic processing, VHP decontamination, E-Beam sterilization, and sterile filtration processes.
• Experience in pharmaceutical, medical device, biotechnology, or other highly regulated industries.
• Knowledge of Lean Manufacturing, Six Sigma, or Continuous Improvement methodologies.
• Experience supporting equipment qualification and process validation activities.

Salary- $126,079 - $157,000/ Annual

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.