Eli Lilly and Company

Cleaning Validation Scientist

Indianapolis, IN, United States
Oct 05, 2018
Required Education
Bachelors Degree
Position Type
Full time
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 39,000 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.

The Cleaning Validation Scientist is responsible for the technical ownership and successful execution of the Cleaning Validation Program at the Indianapolis Parenteral Manufacturing Site. TS/MS Cleaning Validation personnel provide stewardship of the site's Cleaning Validation Program, including assessment of and improvement in existing controls. 44913BR

Basic Qualifications
  • BS in a scientific discipline (Chemistry, Biology, Pharmacy, Engineering or a related field) or 5+ years of cleaning validation 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
  • Maintenance and continuous improvement of the Cleaning Validation program
  • Write validation protocols and reports in support of the site's validation program
  • Investigate and troubleshoot problems which occur during cleaning
  • Plan and execute cleaning validation activities, including cross-functional coordination and internal coordination with Validation Specialists
  • Prepare and provide technical review of completed/executed validation packages by compiling and analyzing validation data for submittal for review and approval
  • Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures
  • Write validation plans and risk assessments related to specific projects, facilities, products
  • Write and review policies and procedures (SOPs)
  • Perform risk assessments for cleaning programs
  • Perform and/or coordinate cleaning studies, spray coverage testing, cleaning verification swabbing, and rinse sampling
  • Provide technical input for control strategies for the introduction of new products (e.g. CTs), as it relates to Cleaning Validation
  • Maintenance of the Cleaning Validation equipment and product matrix
  • Write and execute IQ/OQ/PQ/ and cycle development protocols including development of final reports
  • Represent/defend cleaning validation strategies during internal assessments / audits and external regulatory inspections

Additional Information
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.