QC Equipment Validation Specialist

2 months ago

Concord, United States BioSpace, Inc. Full time
Job Details

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:

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Key Objectives/Deliverables:
  • Author equipment qualification/validation protocols and strategies for the QC Laboratories.
  • Provide support for equipment relocation and qualification associated with Concord Lab master plan.
  • Participate/lead in data integrity controls and improvement initiatives.
  • 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 issues and key operational objectives.
  • Act as liaison between the maintenance team and lab personnel to schedule preventative and corrective maintenance of equipment.
  • Responsible for design and execution of laboratory CSV initiatives, System 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.
  • 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 customer's 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.
Education/Experience Requirements:
  • Bachelor's degree in a science or engineering related field (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
  • 5 or more years of laboratory experience with emphasis on laboratory equipment.
Minimum Requirements:
  • Experience supporting laboratory equipment in a GMP environment.
  • Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
  • Understanding of compliance requirements and regulatory expectations for lab systems.
Additional Preferences:
  • Previous experience with managing data integrity regulations and controls.
  • Working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva
  • Ability to work cross-functionally.
  • Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel.
Other Information:
  • Ability to work 8 hour days - Monday through Friday
  • Ability to work overtime as required.
  • Limited travel may be required during project phase.


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.

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