Manager Business Solutions - Lab IT Systems Lead

About the role

Lilly is entering an exciting period of growth and is investing over $3 Billion to create a new state-of-the-art manufacturing site for Drug Substance in Lebanon, Indiana. This is an opportunity you don’t want to miss!

Responsibilities

• Supports the establishment and maintenance of the validated state of software-based computerized systems and lab instruments in use in the lab.
• Ensures compliance with regulatory requirements and sustainability for local and global Technology at Lilly systems and labs instruments.
• Collaborates with the local and global Computer System Quality Assurance team and Technology at Lilly organization to enable best practices, processes, and governance.
• Supports site deployment and upgrade of laboratory IT systems such as MODA, Empower, NuGenesis, and LabVantage with any CSV needs.
• Partners with Global Quality Laboratory Network, Global and Site IT team members, Computer System Quality Assurance (CSQA), site Quality Assurance, and external vendor/supplier organizations.
• Manages and supports both internal or external audit and inspection activities for the laboratory.
• Performs change control, investigations, root cause analysis, and activity planning.
• Provides oversight and supports continuous improvement of systems/instruments as they relate to the labs.
• Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
• Manages and supports both internal or external audit and inspection activities for the laboratory.
• Performs System Administration for E3B system.
• Coordinates the technical evaluation with site Tech@Lilly subject matter experts (SMEs) of new and existing systems from a Data Integrity and CSV perspective for both labs systems and computerized labs instruments.
• Provides CSV consulting and assists with articulation of CSV needs to the CSV third party service provider(s).
• Leads and participates in DI/CSV related deviations and CAPAs in the scope of LP1 labs area.
• Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only.
• Leads team of contract resources in the management and support of labs instruments.

Qualifications

• Bachelor of Science degree in IT, Engineering, Computer Science, or related field.
• 5+ years of relevant work experience in CSV capacity working in a regulated industry (i.e., GMP).

Skills

• Strong Data Integrity (DI) knowledge with demonstrated background of having implemented solutions to enhance data integrity in both computerized systems and instruments.
• Proficiency with CSV and demonstrated ability to right-size validation based upon risk.
• Solid knowledge of Computer System Validation process and Data Integrity.
• Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.
• Strong analytical and problem-solving skills to identify and resolve technical issues related to Labs systems, configurations, or integrations.
• Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related).
• Adaptability and flexibility to work in a fast-paced environment and manage multiple tasks simultaneously.
• Solid knowledge of Computer System Validation, GAMP, and GMP.
• Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving techniques.
• Effectively prioritize and escalate issues.
• Demonstrated learning agility and curiosity.
• Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $64,500 - $151,800.

Schedule

Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.

Location

Position will be based out of the Lebanon, IN site with ability to travel to other US and global Lilly sites as required.