IDM Asset Delivery C&Q Process Owner

BioSpace; Indianapolis (IN); On-site; USD 64,000 - 168,000; Full time

Job summary

A leading company seeks an IDM Asset Delivery C&Q Process Owner dedicated to improving commissioning and qualification processes within a global healthcare environment. This role requires creating and executing validation deliverables in a GMP context and involves collaboration across various teams to ensure compliance and quality in device assembly projects. Candidates should have experience in a regulated field and a solid background in engineering or science education.

Qualifications

• 3+ years of experience in GMP regulated environment.
• Knowledge of ISPE Best Practices for Commissioning and Qualification.
• Experience in medical device manufacturing preferred.

Responsibilities

• Lead improvement initiatives and drive the C&Q process.
• Maintain active involvement in industry validation standards.
• Educate business partners on C&Q practices and guidelines.

Skills

Process Improvement

Validation Deliverables

Documentation Management

Strong Communication

Technical Writing

Education

Bachelor of Science in Engineering, Computer Science, or related field

Tools

Kneat Gx

Job description

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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 effectively.
• Solid understanding of how a current state of C&Q is impacted by modifications to existing equipment and/or systems.
• Strong documentation management and technical writing skills along with the ability to make process adjustments to address project changes while maintaining compliance.
• Strong communication skills, ability to resolve matters effectively and handle complex tasks.
• Previous involvement in IDM’s C&Q Process, previous medical device manufacturing industry experience, and experience working effectively with Global Quality.
  
  
  

Additional Skills/Preferences

• Previous involvement in IDM’s C&Q Process, previous medical device manufacturing industry experience, and experience working effectively with Global Quality.
• Proficiency in Kneat Gx preferred.
  
  
  

Education Requirements

• Bachelor of Science in Engineering, Computer Science, or related field (or equivalent work experience).
  
  
  

Other Information

• Travel – Projects may incur periodic domestic & international travel (could be up to 10% during certain periods of time as driven by project needs).
  
  
  

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [e-mail] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. Employees are expected to review their job description annually with their supervisor for applicability as part of the Performance Management Employee Objectives setting process. Employee-specific objectives and deliverables should be indicated in Performance Management documentation.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$64,500 - $167,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

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