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 Senior Process Engineer to join the Process Engineering team at BaseCamp. The Senior Process Engineer will lead the equipment lifecycle management, troubleshooting activities for the BaseCamp facility, utilities, and equipment. The Senior 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 in-depth knowledge of GMP operations, production equipment, New Process Introductions, and Process fit.
- Serve as an SME for production equipment and responsible for on-the-floor troubleshooting.
- Proactively identify and remediate automation, technical and/or process issues team and solving issues with minimal guidance
- Manage and report the capability of the equipment, programming, and services used within production.
- Serve as the primary contact for technical support for Manufacturing and Engineering for any process equipment issues.
- Understand impact of changes to implemented processes and mitigates risks through process review while remaining compliant.
- Apply technical expertise to cross-functional teams to provide input and recommendations for improvements while remaining compliant.
- Provide equipment support and expertise in other Engineering functions including Maintenance, Validation, and Capital Engineering
- Author and provide technical expertise for discrepancies, deviations, and/or CAPAs
- Lead process initiatives and deliverables to meet the overall process engineering milestones.
- Support equipment efficiency review and revalidation activities
- Oversee external contractors and vendors during any troubleshooting efforts
- Ensure discrepancies are resolved and closed out to meet project timelines
Requirements:
- A minimum of 8 years of experience in GMP biotech engineering or an FDA regulated manufacturing facility
- BS degree in engineering field or equivalent experience
- Experience in cGMP facility/equipment start-up, processing, and qualification
- Required experience with good documentation practices and cGMP standards
- Ability to work on multiple tasks simultaneously
- Ability to manage priorities, deliverables, and schedule milestones
- Requires strong interpersonal, verbal communication, and technical writing skills
- Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish.
- Experience in Viral vector & Cell/Gene Therapies experience is a plus
The budgeted range for this position is $150,000 - $180,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
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.
Top Skills
Elevatebio Waltham, Massachusetts, USA Office
200 Smith St, Waltham, MA, United States, 02451
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