CSV Associate - QC Support
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.
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.
Position Brand Description:
To provide equipment lifecycle management support to the Parenteral QCL. Main support functions include specifying and purchasing equipment; authoring EQ and Computer System Validation (CSV) packages, managing the EQ and CSV processes, and providing daily operational support of laboratory by ensuring the equipment and associated computer systems are maintained in a qualified state of compliance. The position requires an understanding of corporate quality systems, a detail-oriented quality mindset with an understanding of analytical laboratory equipment and computer systems, knowledge of lab methods to understand intended use of equipment and their failure modes effects. High-quality skills to include: equipment troubleshooting, ability to prioritize, written and oral communication, decision making, interpersonal/people, computer applications, problem solving.
- Author, oversee, and execute equipment qualification/computer system validation (CSV) protocols for the QCL.
- Recommend and specify equipment purchases based on user requirements.
- Work cross functionally lab and site leadership, lab analysts, internal support groups (i.e., QA, GQL, Automation, Engineering, TSMS, etc.) as well as external vendors regarding qualification, validation, equipment system issues, and key operational objectives.
- Responsible for design and execution of laboratory CSV initiatives and deliverables, System Administrator duties, system upgrades, and data integrity.
- Apply knowledge of quality principles, data integrity principles, fundamentals of GMP, federal regulations, corporate standards and practices, and local procedures in the development of qualification/validation protocols and equipment lifecycle management.
- Network with other areas to understand best practices, shared knowledge, participate in global meetings 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.
- Originate and own TrackWise change controls in support of laboratory equipment and CSV systems.
- Originate and investigate TrackWise deviation records.
- Interacting with regulatory agencies and internal and external auditors during inspections.
- Bachelor degree in scientific field or information technology (IT) field
- At least 3 years experience in CSV activities and/or providing substantial support for equipment and/or systems in a GMP environment, 5 years or more experience strongly preferred
- Ability to interpret & apply regulations such as 21CFR Part 11, 210/211, 820
- Familiarity or proficiency with GAMP or other industry methodologies
- Ability to define validation approach for various equipment
- Familiarity or proficiency with computer systems including Microsoft Office products, laboratory computer systems (e.g., Empower, WinKQCL, SoftMax Pro, etc.), CMMS (e.g., GMARS), SmartLab (or other ELN), Darwin (LIMS), MODA, TrackWise, and Quality Docs (EDMS)
- Computer system validation experience including computer system networking, system architecture and data lifecycle management, basic scripting.
- Ability to work in a lab environment including wearing appropriate PPE and other safety required equipment and considerations.
- Ability to work independently and accurately with minimal supervision.
- Ability to make decisions based on knowledge, experience, best practices and requirements.
- Ability to multitask, prioritize and coordinate work to meet customers needs.
- Demonstrated strong math and documentation skills.
- Demonstrated strong technical oral and written communication skills.
- Demonstrated problem solving and investigative skills.
- Ability to work 8 hour days – Monday through Friday
- Ability to cover weekends, holidays, and company shutdowns as needed.
- 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.
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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).