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Automation & MES Engineer Intern

ElevateBio
14 days ago
Full-time
On-site
Waltham, Massachusetts, United States
IT

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

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. 

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.