BioSpace
Overview
Director - Commissioning and Qualification Base pay range: $130,500.00/yr - $191,400.00/yr 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 put people first. 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. 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 ensure 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. Ensure guidance for the development and maintenance of traceability matrices to demonstrate how commissioning testing met user requirements. Develop guidance and work hand-in-hand with project C&Q organization to support schedule and deliver to budget in collaboration with the Process Equipment COE and other key services to maintain a diverse pool of 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. 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. 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 employees are eligible for a company bonus and Lilly offers a comprehensive benefit program, including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, leave benefits, and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion. #WeAreLilly
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Director - Commissioning and Qualification Base pay range: $130,500.00/yr - $191,400.00/yr 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 put people first. 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. 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 ensure 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. Ensure guidance for the development and maintenance of traceability matrices to demonstrate how commissioning testing met user requirements. Develop guidance and work hand-in-hand with project C&Q organization to support schedule and deliver to budget in collaboration with the Process Equipment COE and other key services to maintain a diverse pool of 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. 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. 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 employees are eligible for a company bonus and Lilly offers a comprehensive benefit program, including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, leave benefits, and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion. #WeAreLilly
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