Principal GxP Systems Engineer

4 weeks ago


Norwood, Massachusetts, United States BioSpace, Inc. Full time
About the Role

The Principal GxP Systems Engineer will play a key role in supporting the delivery and administration of the Syncade MES (Manufacturing Execution system). This individual will be responsible for translating process requirements and MES system best practices into practical, usable electronic batch records.

Key Responsibilities
  • Lead the design, development, and implementation of MES solutions using the Syncade platform.
  • Provide technical leadership and guidance to junior engineers and project teams.
  • Install, configure, and maintain Manufacturing Execution Systems utilizing industry best practices.
  • Participate in the Technical Transfer of new products and process from Tech Dev and into Manufacturing.
  • Identify opportunities to improve existing processes, equipment, systems, and infrastructure by utilizing industry best practices.
  • Directly support operations with troubleshooting and issue resolution with respect to computer and automation systems.
  • Participate in validation activities with IT, Manufacturing, and QA related to implementation and on-going support.
  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Requirements
  • A bachelor's degree in Engineering, Computer Science, or other Technical degree.
  • Pharmaceutical or Biotechnology experience required.
  • A minimum 7+ years of experience authoring and/or execution of MES electronic Batch Records.
  • Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations.
  • An understanding of Good Automated Manufacturing Practices (GAMP) and Computer System Validation (CSV).
  • Experience designing recipes based on ISA 95 and ISA 88 standards and best practices.
  • Experience with software development and programming languages such as C#, Java, or SQL.
  • Strong knowledge of MES concepts, including batch management, recipe management, and data collection.
  • Ability to provide off-hours support as necessary.
  • Strong leadership skills, with the ability to mentor and guide junior engineers and project teams.


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