Asset Delivery C&Q Process Owner - IDM

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:

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.

The Indy Device Manufacturing (IDM) Process Engineering Group delivers device assembly equipment in support of new product launches and capacity expansion to global Lilly and non-Lilly locations. A key function of these deliveries is the commissioning and qualification (C&Q) of the equipment. The IDM C&Q Process Owner will be responsible for driving the C&Q process, leading key continuous improvements, and ensuring consistent application of the process across all IDM projects. This role will also assist with C&Q Strategy planning at the beginning of projects, either with or prior to C&Q Leads are assigned to the project. The C&Q process owner will be responsible for maintaining IDM’s User Requirements, ensuring they are aligned with updates to global standards and support continuous improvement efforts and learnings.

Responsibilities:

• Process onboarding/coaching for IDM C&Q leads. Lead improvement initiatives per DRP Governance.
• Member of Validation COP and a liaison between IDM Quality and Process Engineering.
• Run the IDM C&Q Lilly SharePoint site as well as all templates residing in the electronic C&Q system (Kneat).
• Maintain active involvement in ISPE ensuring awareness of industry validation standards, practices, and trends.
• Network with other manufacturing, Quality, and C&Q resources to ensure appropriate practices are followed for equipment delivery projects.
• Provide guidelines and educate business partners on the appropriate application of C&Q practices.
• Implement improvement initiatives associated with the IDM C&Q Program.
• Hold Biweekly/Monthly meetings with contract C&Q leads to share and establish best practices.
• Represent IDM as C&Q SME and is a Kneat Power User (software used for electronic test execution).
• Primary representative for C&Q related questions and answers.
• Own and update Asset Delivery Commissioning and Qualification governing procedures.
• Approver of C&Q templates and changes in the Kneat system.
• Assist leadership with evaluation of new IDM C&Q contractors.
• Assist in the creation of SOWs for contracting services.
• Primary internal resource for C&Q Contractors.
• Represent IDM on the corporate Verification Community of Practice meetings.
• Represent IDM on the Global Kneat Community of Practice meetings.
• Lead monthly meetings with contract C&Q leads.
• Lead standardization efforts and opportunities.
• Maintain global IDM User Requirements and communicate changes as necessary.
• Supports audits as needed in a subject matter expert capacity.
• Lead deviation investigations within TrackWise for Asset Delivery and support deviations for Contract Manufacturing Operations group.

Basic Requirements:

• 3 or more years of experience in a GMP regulated environment.
• Demonstrated experience in creation of and execution of validation deliverables in a GMP regulated environment and ability to effectively work independently and to take initiative especially within a sophisticated network environment.
• Proficiency in equipment and computer system validation as applied in a GMP regulated area.
• Demonstrated knowledge of the ISPE Best Practices Guide for Risk Based Approach to Commissioning and Qualification.
• Solid understanding of external validation standards (e.g., GAMP, ISPE, ICH) and Lilly GQS requirements.
• Previous automated assembly equipment validation experience.
• Demonstrated ability to lead, influence (both internally and externally) and to communicate C&Q process requirements/concepts effe