Job Description

Overview

This role will design, develop, optimize, and support GMP drug product manufacturing and packaging process, including equipment, facilities, and control systems at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed.

Responsibilities

  • Implementing and maintaining manufacturing process automation and control systems.
  • Participate as a member of cross functional teams in completion of system impact evaluations and system risk assessments in a multi-product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced.
  • Assists with the preparation and maintenance of User Requirements Specifications.
  • Ensuring compliance with regulatory requirements (FDA, ...

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