Job Information
Lilly Concord IDS Analyst (Labs) in Concord, North Carolina
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.
Job Description:
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!
Organization Overview:
Manufacturing and Quality Information and Digital Services (MQ IDS) supports manufacturing operational excellence and productivity efforts through utilization of information and technology. MQ IDS strives to enable the making of medicine “with safety first and quality always”
Responsibility:
This IDS Analyst (Laboratory Business Integrator) position at Concord will partner with the quality control functional area and global IDS teams to implement and support digital laboratory solutions to support the organizational objectives of the concord site.
Key Objectives/Deliverables:
Expand the laboratory systems stack knowledge and understand local laboratory procedures.
Support and configure laboratory equipment inside Empower and other systems to ensure correct execution of laboratory testings.
Accurately translate business processes into technical terms and vice versa
Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the quality control laboratory, and ensure that solution requirements comply
Deliver and support laboratory systems stack to start up new quality control lab operations inside the concord site.
Work with global system teams to ensure operational readiness of laboratory systems to support the operational objectives of the concord facility (i.e. validation plans, standard operating procedures, training, etc.)
Produce and maintain project and validation documentation
Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement
Ensure the incident, problem, configuration, and change/release management are all accomplished in alignment with and understanding of business need
Basic Requirements:
Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
At least 1 year of relevant work experience in information technology, engineering, computer system validation, quality control support or related areas
Additional Skills/Preferences:
Prior work experience working in pharma or other GMP setting
Strong working knowledge of quality control laboratory IDS systems (i.e. Empower, Lab Vantage, etc.).
Solid knowledge of Computer System Validation process
Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving skills
Effectively prioritize and escalate issues
Demonstrated learning agility and curiosity
Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions
Desire and ability to communicate using a variety of methods in diverse forums
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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).
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