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.

Key Responsibilities
  • Assist in equipment lifecycle management and troubleshooting activities for the BaseCamp facility, utilities, and equipment.
  • Provide technical and process support for manufacturing suites, working closely with engineering, process development, manufacturing, and Quality Control and Quality Assurance (QA) teams.
  • Participate in on-the-floor troubleshooting and resolve automation, technical, and process issues with cross-functional teams.
  • Understand the capability of equipment, programming, and services used within production.
  • Serve as a point of contact for technical support for Manufacturing and Engineering for process equipment issues.
  • Understand the impact of changes to established processes and work with cross-functional teams to mitigate risks through process review cycles.
  • Provide equipment support for other Engineering functions, including Maintenance, Validation, and Capital Engineering.
  • Author and provide technical support for discrepancies, deviations, and/or 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.
  • Required experience with good documentation practices and cGMP standards.
  • Strong interpersonal, verbal communication, and technical writing skills.
  • Experience in cGMP processes such as Cell Therapy, Gene Therapy, and/or mRNA production.
  • Experience in Cell Cultures/Viral Vectors is a plus.
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.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission: To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision: We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created, and how disease is treated.

ElevateBio is 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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