Lead Quality Assurance Engineer

2 weeks ago


Indianapolis, Indiana, United States RBW Consulting Full time

Principal Quality Engineer

As a leading CDMO partner, we are currently seeking a skilled Principal Quality Engineer to take charge of Equipment and Facility design, as well as Commissioning, Qualification, and Procedural Development for large-scale construction projects.

This position offers significant potential for long-term stability, professional growth, and team leadership, supported by a Global Pharma and Private Equity. With two sites in the midst of expansion and plans to install multiple Sterile Manufacturing lines, you will have clear objectives for your teams and ample projects to engage with.

Key Responsibilities

  • Act as the primary quality contact, overseeing and approving commissioning and qualification activities related to process and facility equipment, including equipment IOPQ, sterility assurance, cleaning validation, and computer systems validation.
  • Apply industry standards and global regulations to the design of cleanrooms and production processes, ensuring compliance and quality.
  • Work collaboratively with cross-functional teams during the design and implementation of new projects, equipment, and systems, providing quality oversight and employing risk management strategies for quality by design.

If you are interested in joining an organization experiencing exciting growth and looking to enhance your team leadership capabilities while ensuring job stability, we encourage you to explore this opportunity further.



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