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 for a curious, self-motivated student who wants more exposure to the field of GxP computer systems and applications while working with a small, experienced Operational Technology (OT) team. You will report to the Associate Director of Operational Technology. This role is located in Waltham, MA. The successful candidate will have a strong technical background and work with the team on projects that support the OT team, including but not limited to: improving team operational efficiency & efficacy, creating and updating knowledge articles, working hands on in a system to test system upgrades (e.g., computer system validation (CSV)), creating and testing electronic batch records (EBRs), and participating in manufacturing support activities.
Here’s what you’ll do:
- Learn about the different aspects of supporting GxP computer systems, which includes these systems/areas: MES, PCS, ERP, LIMS, lab instruments, Computer System Validation (CSV).
- ·Present what you learned and the mini-project of your choosing.
- Additional Opportunities:
- Identify and implement a project for team operations efficiency.
- Support verification of configuration in a PCS or data historian.
- Support a LIMS initial implementation project.
- Provide support for a regulatory audit.
- Design, build, and test an electronic logbook.
- Test electronic batch records.
- Create and update configuration specifications, design specifications, standard operating procedures (SOPs), work instructions (WKIs), and how-to knowledge articles.
Requirements:
- Must be a college student with a major, minor, or interest in automation, computer systems & applications, computer system validation (CSV), chemica engineering, bioengineering, drug product manufacturing & its supporting functions, computer science, computer engineering, or related field.
- Well-organized with demonstrated experience breaking down projects into smaller tasks and executing them.
- A self-starter who seeks out problems and offers solutions.
- A problem solver who is not afraid to be wrong sometimes.
- Good communication, technical writing, & presentation skills with an interest in improving them.
- Familiarity with recipe development and/or basic knowledge of batch manufacturing is preferred.
The budgeted range for this position is $25.00 . This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and, 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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