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Validation Specialist

Indianapolis, Indiana

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Req ID R-34304 Title Validation Specialist City Indianapolis State / Province Indiana Country United States

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 35,000 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:

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Responsibilities:

Advanced pharmaceutical manufacturing experience will be utilized to write, develop and execute the implementation of local technical projects, process improvement activities, and validation activities. Provide support through the preparation and management of the technical components of Change Controls, CAPA events, Manufacturing Tickets, Validation Protocols, Standard Operating Procedures, etc.  Participate within cross-functional teams in a positive fashion to execute validation activities and deliver business plan objectives. 

Key Objectives/Deliverables:

  • Write and execute validation protocols and summary reports

  • Effectively work with operations/support groups to ensure conformance to validation schedule

  • Influence cross-functional process teams to drive technical agenda items or improvement projects

  • Ability to analyze and troubleshoot issues while executing validation protocols

  • GMP documentation of validation data

  • Lead or support validation related investigations 

  • Perform gowning qualification and requalification (as needed)

  • Mentor operators and process team members on validation related topics

  • Identify, lead and implement projects driven from manufacturing process teams or from local functional groups

  • Utilize existing process monitoring software tools to collect, monitor and, if necessary, notify management, Validation Associates, and/or Technical Service Product Reps of adverse trends 

  • Collection of data may include real-time routine data as well as more specialized periodic process data (quarterly or annual)

Basic Qualifications

  • High school diploma/GED

  • Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable

  • Experience in cleanroom control (including validation requirements)

  • Minimum of 5 years of direct cGMP pharmaceutical operations experience

  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences

  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all corporate and site safety goals

  • Ability to effectively prioritize and carry out a variety of tasks and requests related to validation

  • Excellent written and oral communication

  • Must have sufficient computer aptitude to learn the various systems needed to support parenteral plant operations

  • Demonstrated data collection and analysis skills

  • Demonstrated ability to work independently

  • Working knowledge of manufacturing operations

  • Demonstrated leadership skills (i.e. proactive, assertive, ability to positively influence others across multiple levels of organization)

  • Proficient Computer Skills in MS Word and/or MS Excel

  • Demonstrated ability to effectively work in cross-functional teams

  • Demonstrated problem solving experience using scientific-based methodologies

Additional Information:

  • 8 hour days –Monday through Friday

  • Overtime will be required as needed

  • Required to carry cell phone and provide off shift coverage in response to operational issues or validation activities

  • Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

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.


As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

#WeAreLilly

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-34304.

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.

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