Sr Engineering Specialist

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

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

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

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

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.

• 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.

Why Join B. Braun?

At B. Braun, we are committed to protecting and improving the health of people around the world. Through our Sharing Expertise philosophy, employees are empowered to collaborate, innovate, and contribute to meaningful advancements in healthcare. Our team members enjoy opportunities for professional growth while making a direct impact on product quality, operational excellence, and patient safety.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .