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Validation Engineer

2 months ago

Raleigh, North Carolina, United States FUJIFILM Diosynth Biotechnologies Full time
About the Role:

The Commissioning and Qualification (CQV) Engineer 2 plays a crucial role in ensuring the smooth operation of our state-of-the-art manufacturing facility. This position is responsible for coordinating and executing validation activities, including equipment setup, building dashboards, and reviewing documents. The successful candidate will ensure that all equipment and systems comply with regulatory requirements and quality standards.

Key Responsibilities:
  • Configure, test, and validate electronic systems to ensure they meet standards and regulatory requirements.
  • Read and interpret piping & instrumentation diagrams (P&IDs) to identify system components and ensure proper installation.
  • Draft and implement validation protocols to ensure equipment and systems are properly qualified and validated.
  • Coordinate the execution of validation activities, including equipment setup, material readiness, and work orders.
  • Develop and maintain dashboards in Tableau to visualize and analyze CQV data, tracking progress and trends.
  • Identify potential risks and escalate to senior engineers or management for resolution.
  • Prepare and present report packages for implementation into standard operating procedures (SOPs).
  • Develop validation master plans for facilities, equipment, and systems.
Requirements:
  • Bachelor's degree in Engineering with 2 years of experience in validation activities, commissioning, and systems qualifications.
Preferred Qualifications:
  • Master's degree in Engineering with no prior experience.
  • Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry.
  • Prior experience with mammalian cell culture process.