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.
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Career Level
Intern
Education Level
No Education Listed