Lead Quality Assurance Engineer

1 week ago


Indianapolis, Indiana, United States RBW Consulting Full time

Principal Quality Engineer Opportunity

As a prominent player in the Contract Development and Manufacturing Organization (CDMO) sector, RBW Consulting is on the lookout for a seasoned Principal Quality Engineer. This role is pivotal as it involves being the primary liaison for Equipment and Facility design, as well as overseeing Commissioning, Qualification, and Procedural Development for large-scale construction initiatives.

Supported by a Global Pharmaceutical and Private Equity partnership, this position offers significant potential for long-term career stability, professional growth, and leadership development. With two facilities currently expanding and plans to introduce multiple Sterile Manufacturing lines, you will have defined objectives for your teams and a wealth of projects to engage with.

Key Responsibilities

  • Act as the main quality contact, ensuring quality oversight and approval for commissioning and qualification activities related to process and facility equipment, including equipment Installation, Operational, Performance Qualification (IOPQ), sterility assurance, cleaning validation, and validation of computer systems.
  • Possess a thorough understanding of industry standards and global regulations concerning the design of cleanrooms and production workflows.
  • Work collaboratively with cross-functional teams during the design and execution of new projects, equipment, and systems to provide quality oversight and implement risk management strategies that align with quality by design principles.

If you are seeking a dynamic organization in a growth phase that can enhance your leadership capabilities while providing job security, we encourage you to explore this opportunity further.



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