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.
- Work in a Global standards laboratory environment, implementing calibration computer systems to support a variety of software-based systems used throughout the lab. This position will guide and consult with corporate standards lab (CSL) Lead Metrologist, IT, Business Computer Systems (CS) QA and Data Integrity Site Data Leader in meeting Lilly Global Quality Standards (GQS) requirements for CSL computer systems performance in support of CSL business objectives. Provide computer systems and data oversight in the CSL and technical influence in advancing Measurement systems compliance with ALCOA+ Principles. Longer term job goals include computer systems development to help move the lab from manual calibration data entry to automated data transfer and storage using a data historian such as Smart Lab. This is to meet regulatory requirements for Data Integrity.
- This position will influence calibration computer system design, implementation, and sustainment at the local site/network level through systems input leveraging internal and external knowledge.
- This position will influence local and network leadership to impact measurement science computer systems decision making
- Work with QA, IT and Data Integrity (DI) Leader to support and apply risk management to complex lab computer systems issues
- Work with a local validation coordinator and infrastructure/desktop support to implement computer systems upgrades and updates and own related Quality Plan items.
- Coordinate all Systems CSQA and DI procedures and systems requirements including System data assessments and reviews, Procedures gap assessments, participation in DI criticality assessment and systems remediation.
- Mentor - Coach local Metrologists on Computer Systems GQS compliance
- Own CSL Computer systems implementations in support of business objectives. Lead software systems replacement projects and upgrades to keep current.
- Responsible for meeting GQS and Lilly Quality Procedures (LQP) computer systems requirements
- Daily assess and cease any non-compliant computer systems work (work closely in conjunction with the CSL Manager).
- Convey needed resources to CSL Manger - Engineering.
- Use appropriate methods to change, review, and approve documents.
- Direct quality concerns to Quality Assurance.
- Consult with metrologists relative to their computer system metrology needs, especially on compliance issues and investigations
- Bachelor's degree (4 yr. college) in Information systems or engineering, science, statistics, or equivalent experience.
- Minimum 10 years of relevant experience (calibration-related computer systems, including MC Link, MET/TEAM, & LabSolutions software packages experience preferred)
- Experience with developing software solutions for calibration that are ALCOA+ compliant.
- Metrology Experience
- Pharmaceutical, biotech, food, or specialty chemical industry experience preferred.
- Demonstrated ability to perform computer system programming and understand engineering math functions.
- Demonstrated interpersonal skill.
- Demonstrated strong oral and written communication skills.
- Demonstrated capability to efficiently implement complex computer system changes in support of CSL business objectives.
- Demonstrated ability to resolve computer system issues through data driven decision making.
- Demonstrated ability to apply risk management to complex computer related lab issues.
- Proficient with computer systems including Microsoft Office products, Trackwise/CAPA, eMail systems, and computerized maintenance management system (CMMS), GMARS.
- Must be capable of working with a wide variety of people both internal and external to Eli Lilly and Company.
- Expected to field incoming requests in a timely manner.
- Shift is days, M – F. Position is based in Indianapolis, IN and requires onsite presence the majority of the time.
- Minimum travel (< 10% annually) will be required for training and/or vendor audits.
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