Process Engineer II

1 day ago


Waltham, Massachusetts, United States ElevateBio Full time
About the Role

ElevateBio is a pioneering technology-driven company that accelerates the development of cutting-edge genetic medicines. We're seeking a highly skilled Process Engineer II to join our Process Engineering team at BaseCamp.

The successful candidate will play a crucial role in equipment lifecycle management, troubleshooting, and technical support for our manufacturing suites. This includes collaborating with cross-functional teams to resolve automation, technical, and process issues.

Key Responsibilities
  • Provide input on GMP operations, production equipment, and process development.
  • Assist in on-the-floor troubleshooting and participate in resolving technical issues.
  • Understand the capabilities of production equipment, programming, and services.
  • Serve as a point of contact for technical support for Manufacturing and Engineering.
  • Author and provide technical support for discrepancies, deviations, and CAPAs.
  • Support equipment efficiency review and revalidation activities.
Requirements
  • 4+ years of experience in GMP biotech engineering or an FDA-regulated manufacturing facility.
  • BS degree in a related Engineering field in Biotech/Pharmaceuticals.
  • Experience in cGMP facility/equipment start-up, processing, and qualification.
  • Strong interpersonal, verbal communication, and technical writing skills.
  • Experience in cGMP processes such as Cell Therapy, Gene Therapy, and/or mRNA production.
About ElevateBio

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. We commercialize our enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities.

Our ecosystem combines multiple R&D technology platforms with comprehensive cell engineering technologies and an expanded viral and non-viral therapeutic delivery platform. We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

We're committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.



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