Director - Commissioning and Qualification

Job Details
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.
Job Summary: The Global facilities Delivery (GFD) Commissioning and Qualification Director will be responsible for developing, leading and providing oversight to the commissioning and qualification (C&Q) activities for major site capital projects within the Global Facilities Delivery Projects team. This role involves ensuring that GFD has business processes in place for all major project systems and equipment that are properly commissioned and qualified to meet regulatory and business requirements. The lead will work closely with project CQV leaders, project managers and/or engineering teams, to establish and deliver high-quality C&Q programs.
Key Responsibilities:

• Lead the development of effective global safety programs from procedure development, delivery training and coaching to transfer the knowledge to the project CQV leader for execution in the field during project.
• Develop and ensuring implementation of comprehensive C&Q strategies for major capital projects, including parallel commissioning of multiple production facilities and support buildings in a GMP and process safety regulated environment.
• Create guidance that will transfer to the project C&Q lead to managing the development of CQ strategies and execution plans, schedule, and budget to ensure timely and cost-effective delivery.
• Provide technical oversight and guidance to the C&Q team, ensuring adherence to industry standards and best practices.
• Coordinate with project C&Q Leaders and teams to assess, provide direction, and oversee the implementation of engineering and construction services
• Ensuring we have guidance for the development and maintaining traceability matrices to demonstrate how commissioning testing met user requirements
• Develop guidance and work hand-to-hand with project C&Q organization to support schedule and deliver to budget in collaboration with the Process Equipment COE and other key professional services to maintain a diverse and capable pool of service providers.
• Monitor and understand market conditions to educate and influence project decisions with current data

Qualifications:

• Bachelor's degree in engineering, related science or Project Management, or a related field.
• Minimum of 10 years of experience in commissioning and qualification activities within the pharmaceutical or biotech industry.

Preferred Qualifications:

• Proven track record of managing large-scale C&Q programs from design phase through to closeout and handover.
• Strong knowledge of ASTM E2500 Model and Verification methodology.
• Excellent leadership, communication, and organizational skills.
• Ability to work effectively in a cross-functional team environment.
• Experience with major site projects and pharmaceutical & process safety processes.
• Familiarity with regulatory requirements and industry standards for commissioning and qualification
• Certification in project management (PMP or equivalent) is a plus.

Work Environment:

• Regular collaboration with project managers, engineering teams, and quality assurance

Other Information:

• Domestic and International travel is likely in this role including weekends and multi-week stays. Travel of approximately 15% to 30% away from home

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 ( ) 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
$130,500 - $191,400
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
Company
Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.
Company info
Location 893 S Delaware St
Indianapolis
Indiana
46285
United States
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