Sr Engineering Specialist
$126.08k - $157kB. Braun Melsungen
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
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®.
- 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.
- 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.
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 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.
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