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Computer System Validation Analyst-FDE United States,  

Lilly (company)

Posted on : 13 May 2017

Project Description

Computer System Validation Analyst-FDE
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 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.
Computer Systems Validation (50%)
  • Provide strategic guidance on applying right-sized, risk-based approach to CSV.
  • Supply technical guidance on corporate and site CSV policies and procedures.
  • Ensure CSV deliverables are appropriately reviewed and meet all requirements of corporate and site CSV policies and procedures.
  • Implement processes to maintain CSV compliance.
  • Escalate CSV issues immediately to appropriate people.
  • Apply/share standard CSV best practices across Lilly.
  • Partner with customers to understand the business.
  • Create, revise, and implement CSV related documentation, ensuring all document are well written, usable/executable, and compliant with Corporate and Local policies and procedures

Business Integrator and Analyst (50%)
  • ITS: Build a deep Information Technical Services  capability, including knowledge/expertise of document management, IT processes, and business processes at Indy Dry.
    • Effectively influence the business to drive value and implement appropriate solutions.
    • Accurately translate business process, which may span multiple areas, into technical terms, and vice versa.
    • Use and drive risk base decision-making.
  • Application Knowledge: Be an expert and resource in the business use of various applications (Including, but not limited to: GMARS, Regulus, ALM, and Service Now) that the site uses to ensure the systems remain in a validated state
  • Account Management: Serve as an account manager and lead integrator for various functional areas, working with the business to identify and capture new opportunities, improve process and optimize the value IT can provide.
  • Technologist
    • Assess technical solutions provided by central the MQIT team.
    • Evaluate and translate functional requirements into technical solutions.
    • Resolve challenging issues via break-fix testing, incidents, and/or change/service requests
  • Bachelor s Degree
  • Minimum 3 years of experience with Computer System Validation
  • 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
  • Strong problem-solving, analytical and process improvement skills
  • Good verbal and written communication skills
  • Demonstrated ability to proactively identify issues and either resolve or escalate to the appropriate level for resolution
  • Experience with process improvement
  • Previous experience operating in a GxP work environment
  • Self-motivated
  • Curiosity about business and IT processes
  • Working knowledge of IT applications utilized within Indy Dry Product manufacturing.
  • Knowledge of Indy Dry Product manufacturing.
  • Working knowledge of MQIT CSV practices, including system periodic reviews, external/internal audits
  • Off hours work sometimes required to implement initiatives and/or support a 24x7 manufacturing and packaging site.
  • This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
  • 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


Indiana, United States

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