MQ Tech at Lilly QC Labs Analyst

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 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,750 - $145,200

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. This is an exciting once-in-a-lifetime opportunity to work in a state-of-the-art manufacturing site, in Pleasant Prairie, Wisconsin.

The facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. The Lilly Kenosha site will leverage use of high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

As an MQ Tech at Lilly QC Labs Analyst, your will partner with the quality control functional area and global Tech at Lilly teams to implement and support digital laboratory solutions to support the organizational objectives of the Concord site. You will also play a key role as Process Team member to have direct ownership of the day-to-day operations at the Labs representing the Tech at Lilly function

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 testing.

• 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 Kenosha site.

• Work with global Tech at Lilly teams to ensure operational readiness of laboratory systems to support the operational objectives of the Kenosha facility (i.e. validation plans, SOPs, 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.

• 1+ year of relevant work experience in information technology, engineering, computer system validation, quality control support or related areas.

• Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.

• Solid knowledge of Computer System Validation process.

Additional Preferences:

• Master’s degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field.

• Strong working knowledge of quality control laboratory IT systems (i.e. Empower, Lab Vantage, etc.).

• 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). Effectively prioritize and escalate issues.

• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.

• 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). Effectively prioritize and escalate issues.

• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.

• Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions.

• Understanding of cybersecurity concepts and best practices related to Labs technologies.

• Build solutions using an agile framework for the entire solution lifecycle including designing, implementing, automating, modernizing, maintaining, and optimizing solutions.

• Experience with Computer System Validations.

• Experience with technical mentoring and developing technical team members.

• Exposure to international operations, diverse teams, global IT projects, or working in a global organization.

Other Information:

• 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.

• Position will be based in the Pleasant Prairie area in Wisconsin with ability to travel to Indianapolis and other global Lilly sites as required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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