Process Engineer II

1 week ago

Waltham, United States ElevateBio Full time

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

ElevateBio is looking to hire a Process Engineer II to join the Process Engineering team at BaseCamp. The Process Engineer will assist in the equipment lifecycle management, troubleshooting activities for the BaseCamp facility, utilities, and equipment. The Process Engineer will provide technical and process support for the manufacturing suites on site working facilities, engineering, process development, manufacturing, and Quality Control and Quality Assurance (QA) teams.

Here's What You'll Do:

  • Provide input on GMP operations, production equipment, New Process Introductions, and Process fit.
  • Assist and participate in on-the-floor troubleshooting. Participate in resolving automation, technical and/or process issues with cross-functional teams.
  • Understand the capability of the equipment, programming, and services used within production.
  • Serve as a point of contact for technical support for Manufacturing and Engineering for process equipment issues.
  • Understands impact of changes to established processes and works with cross-functional teams to mitigate risks through process review cycles.
  • Provides 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.
  • Requires strong interpersonal, verbal communication, and technical writing skills.
  • Experience in cGMP processes such Cell Therapy, Gene Therapy, and/or mRNA production.
  • Experience in Cell Cultures/Viral Vectors experience is a plus.


Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

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. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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