Job Information
Lilly Manager - Site Computer System Validation (CSV) in Lebanon, Indiana
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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$63,750 - $145,200
This is an opportunity you don’t want to miss!
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. LRL has increasing needs for in-house manufacture of material for clinical supplies and will therefore construct a new campus to manufacture Clinical Trial (CT) Active Pharmaceutical Ingredient (API) to meet needs for an expanding portfolio (more and new areas), to accelerate development timelines, and to enhance supply chain robustness.
The brand-new facility also known as Lilly Medicine Foundry (LMF) will utilize the latest technology to augment the current clinical supply chain for small molecules (SM), oligonucleotides, peptides, and Antibody Drug Conjugates (ADCs), monoclonal antibodies and bioconjugates, and add new capabilities including mRNA. The new 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.
What You'll Be Doing:
This is a unique opportunity to be a part of the team for the startup of a greenfield clinical development manufacturing site, and the successful candidate will help to design, commission, and start up the facility for clinical supply.
This role will provide CSV technical leadership across the different IT groups in the Lilly Medicine Foundry focused on external regulations, industry best practices, policies and procedures governing the process to validate, maintain and retire new and existing computer systems. The position will be responsible for defining and maintaining CSV local policies and procedures to ensure that all solutions deployed are developed and implemented according to enterprise policies and regulatory requirements. This role will collaborate within the Lilly Technology team and Quality organizations and externally with industry forums and standard to ensure the state of compliance of computer systems.
How You'll Succeed:
Technical Leadership: Provide computer system validation (CSV) technical leadership, ensuring compliance with external regulations and industry best practices.
Policy & Procedure Development: Define and maintain local policies and procedures for CSV to ensure solutions are developed and implemented according to enterprise policies and regulatory requirements.
Collaboration: Work closely with internal IT and Quality organizations, as well as external industry forums and standards, to maintain the state of compliance of computer systems.
Mentorship and Education : Provide CSV, mentoring, and training to peers on computer system validation topics, systems and processes, support audits, and oversee management reviews, validation and compliance metrics
Facility Startup: Contribute to the design, commissioning, and startup of the new clinical development manufacturing site for clinical supply.
What You Should Bring:
Advanced Degree: Master’s degree in a related field.
Experience with Startups: Previous experience in the startup of a new facility or clinical development manufacturing site.
Leadership Skills: Proven leadership experience in managing cross-functional teams.
Industry Engagement : Active participation in industry forums and standards organizations.
Problem-Solving: Strong analytical and problem-solving skills with a proactive approach to addressing challenges.
Certifications : Relevant certifications such as Certified Computer System Validation Professional (CCSVP), Good Automated Manufacturing Practice (GAMP) 5 or Certified Quality Auditor (CQA):
Basic Requirements:
Education : Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field.
Experience : Minimum of 5 years of experience in computer system validation within a regulated industry (e.g., pharmaceuticals, biotechnology).
Knowledge : Demonstratable minimum 5 years experience with strong understanding of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP, 21 CFR Part 11).
Skills : Demonstratable minimum 5 years experience with excellent technical writing, communication, and project management skills.
Organization Overview
Lilly IT builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Lilly IT is that we redefine what’s possible through tech to advance our purpose – creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of our business.
Research Tech unites science with technology to accelerate the Research and Development of medicines and to deliver therapeutic innovations. The team leverages technology and platforms to streamline scientific experimentation to help Researchers follow the science, to understand the disease and identify potential therapies. They are at the forefront of advanced analytics to enable data driven drug discovery, to innovate so Scientists can rapidly analyze and accelerate the discovery of new medicines.
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 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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.
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