Automation & MES Engineer Intern

ElevateBioWaltham, MA
1d$25 - $25Onsite

About The Position

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.

Nice To Haves

  • Familiarity with recipe development and/or basic knowledge of batch manufacturing is preferred.

Responsibilities

  • 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.
  • 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.
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