ElevateBio is a cell and gene therapy technology company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies.
ElevateBio is looking for a Process Engineer II to support executing tech transfer projects for various clinical programs to be manufactured at our Waltham facility as well as facility expansion projects. In this role, you will be responsible for developing process equipment list, procurement management, delivery & installation, supporting C&Q team and vendors for equipment qualification and supporting the release of equipment for GMP manufacturing.
Here’s What You’ll Do:
- Lead engineer for tech transfer projects for clinical programs and facility expansion projects
- Equipment gap assessment, equipment list, and specifications
- Manage the equipment procurement, delivery, and installation
- Provide engineering support to the Automation, CQV, and vendors for equipment qualification and GMP release
- Develop and execute engineering tests and other startup activities
- Serve as Subject Matter Expert for operational support, deviation investigation, and CAPA close-out
- Lead or manage small capital projects to support business needs
- Promote engineering best practices, Elevate SOPs, and cGMP regulations
- Cross-functional team collaboration
- Site support to the manufacturing, process development, and facilities teams
- 6-8 years of experience in biotech engineering or an FDA regulated manufacturing facility
- BS degree in Chemical engineering or related engineering field
- Experience in cGMP facility/equipment design, installation, and start-up
- Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish
- Strong understanding of commissioning & qualification, risk-based approach, and engineering lifecycle management of GMP systems
- Required experience with good documentation practices and cGMP standards
- Ability to work on multiple tasks simultaneously
- Ability to manage priorities, deliverables, and schedule
- Requires strong leadership, verbal communication, and technical writing skills
- Viral vector & Cell/Gene Therapies experience is a plus
- Experience in single-use technologies is highly desirable
- Automation knowledge in MES/DeltaV/Unicorn is a plus
Why join ElevateBio?
ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.
At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies
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.