Commissioning And Qualification Engineer

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

Main Purpose and Objectives of Position:

The primary responsibility of this role will be to own the Commissioning and Qualification business process for the Concord site. The Commissioning and Qualification (C&Q) Lead will support the Concord Engineering department by ensuring equipment is installed and maintained according to Lilly quality standards.

This also includes ownership of the various SOPs and templates, management of C&Q resources (where applicable) and supporting specific projects with technical and Qualification guidance.

Key Responsibilities:

• Establishes plans and drives equipment qualification processes per Lilly requirements.
• Owner of SOPs and Templates related to the C&Q Business Processes (e.g. User Requirements, Asset Risk Assessments, Qualification Review Summary, etc.). 
• Lilly sponsor for contract C&Q resources supporting projects
• Responsible for overall C&Q cost performance relative to site target
• Coordinate with team members and QA on improvements to the processes / templates
• Promote Lean practices within the C&Q team (e.g. visibility boards & huddles)
• Maintain connectivity across Lilly as well as local industry to drive aligned best practices

Role Requirements:

• BS Engineering
• 5+ years C&Q experience working in the Life Sciences industry including, operations, or manufacturing with technical experience in finished product storage and operations.
• Demonstrated leadership and people management skills.
• Knowledge of GMP’S, regulatory requirements, equipment Commissioning and Qualification.
• Good written and verbal communication skills with both technical and non-technical staff.

Preferences:

• KNEAT Paperless Validation System experience

Additional Information:

• Due to the nature of this role, this position is not eligible for remote work opportunities.

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