Sr. Principal Associate - QA, Computer System Validation

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 & Responsibilities:

The Analytical Quality & Integrated Services team within the Global Quality Analytical Sciences & Quality Control Operations (AQCO) organization is seeking a Computer Systems Validation (CSV) Specialist to be responsible for qualifying and managing instrument software updates, handling change controls, writing CSV documents, and performing validation testing to ensure compliance with regulatory requirements and company standards. This individual will:

• Manage Instrument Software Updates:
  • Coordinate and implement software updates for laboratory instruments and computer systems.
  • Ensure all updates are documented and validated according to company procedures.
• Change Control Management:
  • Handle change control processes for computer systems and software.
  • Assess the impact of changes and ensure proper documentation and approval.
• CSV Documentation:
  • Write and review CSV documents, including validation plans, protocols, reports, and standard operating procedures (SOPs).
  • Maintain accurate and up-to-date records of all validation activities.
• Validation Testing:
  • Perform validation testing for computer systems and software to ensure they meet predefined specifications and regulatory requirements.
  • Document test results and address any discrepancies or issues.
• Compliance and Quality Assurance:
  • Ensure all validation activities comply with relevant regulatory guidelines (e.g., FDA, GxP, ISO).
• Collaborate cross functionally across and outside of the organization to ensure qualifications are in compliance with regulatory and GMP expectations
• Participate in internal and external audits as required.

Basic Requirements: 

• Bachelor’s degree in Life Sciences field, Engineering, Pharmacy, Pharmaceutical Science, or related field
• At least 10 years of experience in the pharmaceutical industry.
• Experience/knowledge of laboratory activities from the whole product life cycle, i.e. development through commercialization and implementation in Quality Control laboratories.
• Strong understanding of cGMPs, quality systems, and other regulatory requirements.
• Experienced in Root Cause Analysis (RCA) and change control processes.
• Excellent written and verbal communication skills, with meticulous attention to detail including proven experience in technical writing within a life sciences or pharmaceutical laboratory environment.
• Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills.
• Expertise with laboratory instrument qualification and Computer System Validation.
• Ability to interpret and present scientific data in a clear and concise manner.

Additional Skills/ Preferences ​

• Proficiency in document management systems such as Veeva Quality Docs, Kneat, and Microsoft Office Suite.
• Proficiency in TrackWise.
• Technical understanding of the quality systems and regulatory requirements.
• Manufacturing Site experience.
• Knowledge of/Proficiency in laboratory activities related to the product lifecycle.
• Proficient in data analysis and reporting tools.

Additional Information

• This role is located in Indianapolis, IN at Lilly Technology Center - North (LTC-N)

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

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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