CSV Associate - QC Support at Eli Lilly and Company (Indianapolis, IN)

| Indianapolis, IN
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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:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:
  • Author equipment qualification/validation protocols for the QCL.
  • Technical review and execution of qualification/validation protocols.
  • Recommend and specify equipment purchases based on user requirements.
  • Communicate with other functions and external vendors regarding qualification, maintenance issues, and key operational objectives.
  • Act as liaison between the building scheduler, maintenance shops and lab personnel to schedule preventative and corrective maintenance of equipment.
  • Responsible for design and execution of laboratory CSV initiatives and deliverables, System Security Administrator duties, system upgrades, and data integrity.
  • Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management.
  • Interact effectively with customers, support groups and development.
  • Network with other areas to understand best practices, share knowledge, participate in global meetings and web seminars, and to ensure customer needs are met.
  • Influence improvements and streamline quality systems relating to equipment.
  • Serve as equipment expert and technical resource in the review of technical documents.
  • Act as subject matter experts and originator of change controls.
  • Originate and investigate TrackWise CAPA records.
  • Interact with Global Quality Lab Equipment function to set global corporate policy regarding equipment.
  • Ability to multitask, prioritize and coordinate work to meet customers needs.
  • Demonstrate problem solving and investigative skills.
  • Ability to make decisions based on knowledge, experience, best practices and requirements.
  • Ability to work independently and accurately with minimal supervision.


Basic Requirements:
  • Bachelor degree in scientific field related to the lab (Chemistry/Biology/Microbiology/Engineering)
  • At least 3 years laboratory experience in QC or development lab and/or providing substantial support for equipment and/or systems in a in a GMP environment


Additional Skills/Preferences
  • Ability to work 8 hour days - Monday through Friday
  • Ability to work overtime as required.
  • Ability to carry cell phone off shift and respond to operational issues as required.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  • Working knowledge of CMMS, SmartLab, TrackWise, Quality Docs/Veeva Vault.


Additional Information:
  • Minimal travel required.
  • 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 ( [email protected] ) 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.

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. If you would like to request an accommodation for medical or religious reasons, you may do so at [email protected]

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-25876.

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.
More Information on Eli Lilly and Company
Eli Lilly and Company operates in the Biotech industry. The company is located in Indianapolis, IN and Indianapolis, IN. Eli Lilly and Company was founded in 1876. It has 39451 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 132 open jobs at Eli Lilly and Company, click here.
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