Lab IT Systems Lead — Validation & Data Integrity
Eli Lilly and Company
4 hours ago
On-site
Lebanon, IN
IT
What You’ll Be Doing
- Lead and/or support laboratory validation of laboratory equipment and software systems, including computerized analytical instrument qualification (IQ/OQ/PQ) and computerized system validation across GAMP 5 software categories.
- Establish and maintain the validated state of software-based computerized systems and lab instruments; own periodic review cycles to confirm ongoing compliance and fitness for intended use.
- Partner cross-functionally with site DI SMEs to meet DI/CSV expectations (e.g., audit trail management, workstation security, connecting stand-alone equipment).
- Support deployment and upgrade of laboratory IT systems (e.g., MODA, Empower, NuGenesis, LabVantage) with CSV needs.
- Partner with Global Quality Laboratory Network, Global/Site IT, CSQA, site Quality Assurance, and external vendors/suppliers.
- Provide oversight and support continuous improvement of lab systems/instruments.
- Apply quality principles, cGMP, and laboratory systems to develop and execute local procedures, training, and practices.
- Manage and support internal/external audit and inspection activities for the laboratory.
- Perform change control, investigations, root cause analysis, and activity planning.
- Perform System Administration for the E3B system.
- Coordinate technical evaluation of new/existing systems from a Data Integrity and CSV perspective for lab systems and computerized lab instruments.
- Provide CSV consulting and define CSV needs to CSV third-party service providers.
- Lead and participate in DI/CSV deviations and CAPAs in the LP1 labs scope.
- Ensure information assets are protected; restrict access to authorized personnel.
- Lead a team of contract resources managing and supporting lab instruments.
What You Should Bring
- Strong Data Integrity (DI) knowledge and experience implementing DI solutions for computerized systems and instruments.
- Proficiency with CSV; ability to right-size validation based on risk.
- Solid knowledge of Computer System Validation and Data Integrity.
- Excellent communication and interpersonal skills.
- Strong analytical/problem-solving skills; ability to analyze, anticipate, and resolve complex technical/operational issues.
- Ability to prioritize and escalate issues.
- Adaptability and ability to manage multiple tasks in a fast-paced environment.
- Solid knowledge of CSV, GAMP, and GMP.
- Learning agility and curiosity.
- Ability to translate quality control business processes into IT requirements/solutions.
Basic Qualifications
- Bachelor of Science degree in IT, Engineering, Computer Science, or related field.
- 5+ years of relevant CSV experience in a regulated industry (e.g., GMP), with strong understanding of IT quality processes for manufacturing.
Additional Preferences
- Cybersecurity concepts and best practices.
- Agile framework experience across the solution lifecycle.
- Technical mentoring/developing team members.
- International/global exposure.
- Previous Agile experience.
- Experience deploying new system implementations.
- Experience standing up greenfield facilities.
Other Information (Role/Location)
- Monday through Friday; based on-site in Lebanon, IN. Flexible to support production schedules/shutdowns; occasional extended/off-hour work.
- Ability to travel to other US and global Lilly sites as required.
- Lead and/or support laboratory validation of laboratory equipment and software systems, including computerized analytical instrument qualification (IQ/OQ/PQ) and computerized system validation across GAMP 5 software categories.
- Establish and maintain the validated state of software-based computerized systems and lab instruments; own periodic review cycles to confirm ongoing compliance and fitness for intended use.
- Partner cross-functionally with site DI SMEs to meet DI/CSV expectations (e.g., audit trail management, workstation security, connecting stand-alone equipment).
- Support deployment and upgrade of laboratory IT systems (e.g., MODA, Empower, NuGenesis, LabVantage) with CSV needs.
- Partner with Global Quality Laboratory Network, Global/Site IT, CSQA, site Quality Assurance, and external vendors/suppliers.
- Provide oversight and support continuous improvement of lab systems/instruments.
- Apply quality principles, cGMP, and laboratory systems to develop and execute local procedures, training, and practices.
- Manage and support internal/external audit and inspection activities for the laboratory.
- Perform change control, investigations, root cause analysis, and activity planning.
- Perform System Administration for the E3B system.
- Coordinate technical evaluation of new/existing systems from a Data Integrity and CSV perspective for lab systems and computerized lab instruments.
- Provide CSV consulting and define CSV needs to CSV third-party service providers.
- Lead and participate in DI/CSV deviations and CAPAs in the LP1 labs scope.
- Ensure information assets are protected; restrict access to authorized personnel.
- Lead a team of contract resources managing and supporting lab instruments.
What You Should Bring
- Strong Data Integrity (DI) knowledge and experience implementing DI solutions for computerized systems and instruments.
- Proficiency with CSV; ability to right-size validation based on risk.
- Solid knowledge of Computer System Validation and Data Integrity.
- Excellent communication and interpersonal skills.
- Strong analytical/problem-solving skills; ability to analyze, anticipate, and resolve complex technical/operational issues.
- Ability to prioritize and escalate issues.
- Adaptability and ability to manage multiple tasks in a fast-paced environment.
- Solid knowledge of CSV, GAMP, and GMP.
- Learning agility and curiosity.
- Ability to translate quality control business processes into IT requirements/solutions.
Basic Qualifications
- Bachelor of Science degree in IT, Engineering, Computer Science, or related field.
- 5+ years of relevant CSV experience in a regulated industry (e.g., GMP), with strong understanding of IT quality processes for manufacturing.
Additional Preferences
- Cybersecurity concepts and best practices.
- Agile framework experience across the solution lifecycle.
- Technical mentoring/developing team members.
- International/global exposure.
- Previous Agile experience.
- Experience deploying new system implementations.
- Experience standing up greenfield facilities.
Other Information (Role/Location)
- Monday through Friday; based on-site in Lebanon, IN. Flexible to support production schedules/shutdowns; occasional extended/off-hour work.
- Ability to travel to other US and global Lilly sites as required.