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Senior Process Engineer

2 months ago


Carlsbad, United States F. Hoffmann-La Roche Gruppe Full time
About the Role

We are seeking a highly skilled Senior Process Engineer to join our team at F. Hoffmann-La Roche Gruppe. As a key member of our manufacturing team, you will be responsible for driving stable and reliable production for new manufacturing processes recently transferred to production.

Key Responsibilities
  • Develop and characterize manufacturing processes, including surface treatment and precision dispensing of fluids and adhesives.
  • Create and maintain process input and output specifications.
  • Perform capacity analyses, troubleshooting, testing, and support for existing products and new product lines.
  • Lead project teams to drive process development, characterization, and improvement activities.
  • Apply statistical methods to monitor, track, and trend production performance datasets.
  • Investigate issues and communicate findings in a timely manner.
  • Apply standard project management tools and principles to ensure project success.
  • Partner with Product Development for transfer and validation activities for new product launches.
Requirements
  • Bachelor's degree in Engineering or related technical discipline, or M.S. degree with 4+ years of related experience.
  • 6+ years of experience in process development for Medical Devices or pharmaceuticals.
  • Experience in designing and implementing manufacturing processes, equipment, and fixtures.
  • Demonstrated working knowledge of pharmaceutical/medical device cGMPs and FDA compliance.
  • Experience with surface treatment, laser bonding, and dispensing.
  • Proficient in computer software programs such as Word, Excel, Visio, PowerPoint, and SolidWorks.
Preferred Qualifications
  • Experience understanding the design process and its impact on manufacturing.
  • Experience delivering technical presentations to project leaders.
  • Experience in a matrix environment with effective verbal and written communication skills.
  • Demonstrated time management and organizational skills in a dynamic environment.
Work Environment

The essential functions of the job are usually performed in an environmentally controlled facility with moderate noise levels. The employee may be exposed to hazardous chemicals, blood-borne pathogens, and automated equipment.

The expected salary range for this position is $78,800 - $146,300. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.