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Associate Validation Engineer
Confirmed live in the last 24 hours
Locations
Devens, MA, USA
Experience Level
Intern
Requirements
  • Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical or mechanical preferred), a related discipline, or its equivalent
  • Co-op or internship experience in biopharmaceutical industry including experience with manufacturing equipment support in the Biotechnology manufacturing industry is desired
  • Familiarity with or interest in process equipment and system qualification
  • Familiarity with or interest in distributed control systems and automation (GAMP) validation concepts may enable this individual to participate in cross-functional validation efforts
  • Excellent project management, communication, and technical writing skills are required
  • Demonstrated effectiveness in both a team environment and an individual contributor role
Responsibilities
  • Executes with guidance from validation engineers or management the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System) in a highly automated biologics manufacturing facility
  • Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V)
  • Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade)
  • Executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs
  • Executes technical work assignments as a point of contact for project stakeholders
  • Maintains familiarity with BMS directives and industry guidelines on qualification/validation
  • Provides, in addition to operations support, internal compliance and/or efficiency improvement efforts within department for less complex processes
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.