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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.

Position Description:

Lilly is a state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help a state-of-the-art facility and Quality System. The Quality Control Laboratory assures patients worldwide have safe and efficacious drug and device products, through effective execution of product testing.

This role will provide equipment lifecycle management support to the QC Laboratory. Primary responsibilities will include routine and corrective maintenance activities, equipment troubleshooting, qualification and decommissioning of equipment, and maintaining equipment records in electronic protocol and calibration management systems. The position requires an understanding of quality systems and principles, attention to detail, strong organizational skills, along with an understanding of analytical/microbiological laboratory equipment, knowledge of laboratory methods, and an understanding of equipment intended use and failure modes effects. High-quality skills to include: microbiological equipment troubleshooting, ability to prioritize, written and verbal communication, decision making, interpersonal skills, computer applications, problem solving.

Key Objectives/Deliverables:

+ This position requires an understanding of microbiological laboratory equipment, such as isolators, incubators, and autoclaves.

+ Knowledge of lab methods to understand intended use of equipment and their failure modes.

+ Assist in the selection, implementation, maintenance and continuous improvement of equipment within the QC laboratory.

+ Identify compliance and data integrity issues related to QC equipment and implement effective resolutions.

+ Provide support, troubleshooting and maintenance of QC equipment.

+ Act as a liaison between facilities/maintenance groups and laboratory personnel to schedule preventative and corrective maintenance of equipment.

+ Provides post implementation support for equipment.

+ Author and manage change controls and deviations related to QC Equipment.

+ Ability to multitask, prioritize and coordinate work to meet customers' needs.

+ Demonstrate problem solving and investigative skills.

+ Ability to make decisions based on knowledge, experience, best practices and requirements.

+ Ability to work independently and accurately with minimal direction.

+ Escorts and oversees instrumentation/equipment service providers while on site performing instrument maintenance/qualification activities.

+ Supports the establishment and maintenance of the validated state of sterility isolators, autoclaves, parts washer, controlled temperature unit systems in the laboratory.

+ Assist in improvement of quality systems by creating or revising worksheets, developing, or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems

Preferred attributes but not required:

+ Understanding of quality principles and regulatory requirements.

+ Proficient with the operation of microbial laboratory equipment to include sterility isolator, autoclave, controlled temperature units, and parts washer.

+ Experience in handling quality deviations, impact assessments, root cause analysis.

+ Previous experience in a GMP regulated environment.

+ Understanding of laboratory equipment qualification

+ Demonstrating strong oral, written communication and interpersonal interaction skills.

+ Demonstrated proficiency in analytical equipment maintenance.

+ Proficiency with computer systems including computerized calibration management systems (E.g., Maximo, Blue Mountain RAM), chromatography systems, electronic laboratory systems (E.g., LES, LIMS, ELN).

+ Ability to focus on continuous improvement.

**Additional Information** :

+ Ability to work 8-hour days – Monday through Friday

+ May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.

+ Ability to carry cell phone off shift and respond to operational issues as required.

Minimal travel required.

Requirements (Education, Experience, Training):

Bachelor's degree in a scientific field related to the laboratory (e.g. chemistry, microbiology or biology) with a minimum of 3-5 years with equipment metrology.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$63,000 - $162,800

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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