Senior Scientist, Quality Control - Equipment

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.

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 Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future.  As a result, Lilly is looking for experienced quality assurance associates to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Scientist, Quality Control – Equipment, is responsible for asset delivery and maintenance in the Quality Control Laboratory. This role requires an understanding of corporate quality systems, a detail-oriented quality mindset with an understanding of analytical/microbiology laboratory equipment, knowledge of lab methods to understand intended use of equipment and their failure modes and effects. The individual in this position must possess skills which include equipment troubleshooting, prioritization, written and oral communication, decision making, strong interpersonal/people management, computer applications, and problem-solving.

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Authors equipment qualification/validation protocols and strategies for the QC Laboratories.
• Provides support for equipment relocation and qualification associated with Lab master plans.
• Participates in data integrity by design, mitigation through controls and improvement initiatives.
• Executes technical review and execution of qualification/validation protocols.
• Recommends and specifies equipment purchases based on user requirements.
• Communicates with other functions and external vendors regarding qualification issues and key operational objectives.
• Acts as liaison between the maintenance team and laboratory personnel to schedule preventative and corrective maintenance of equipment.
• Applies knowledge of quality principles, cGMPs, regulations, corporate standards, practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management.
• Interacts effectively with support groups and vendors.
• Networks with other areas to understand best practices and share knowledge to ensure customer needs are met.
• Identifies improvements and streamlines quality systems relating to equipment.
• Serves as equipment subject matter expert in the review of technical documents.
• Acts as subject matter expert and originator of change controls.
• Originates and investigates deviations in the QC laboratory.
• Multitasks, prioritizes, and coordinates work to meet laboratory’s needs.
• Demonstrates problem solving and investigative skills.
• Makes decisions based on knowledge, experience, best practices and requirements.
• Works independently and accurately with minimal supervision.
• Performs routine maintenance and repairs.
   

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific Quality Control and laboratory equipment experience.
• On-site presence required.

Additional Skills/Preferences:

• Fluent in English.
• Demonstrated understanding of cGMP regulations.
• Experience supporting laboratory equipment in a GMP environment, including ability to repair and maintain instruments
• Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
• Understanding of compliance requirements and regulatory expectations for laboratory systems.
• Previous experience with managing data integrity regulations and controls.
• Working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva.
• Deep understanding of compliance requirements and regulatory expectations 
• Demonstrated accuracy and proficiency in analytical skills.
• Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
• Excellent written and oral communication skills 
• Previous LEAN experience: ability to drive continuous improvement.
• Strong technical aptitude and ability to train and mentor others. 
• Project management experience.
• Demonstrated problem-solving and decision-making capability.
• Demonstrated technical writing skills 
• Understanding of statistical tools and analyses.
• Strong documentation skills and attention to detail.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Previous regulatory inspection readiness and inspection execution experience.

Additional Information:

• Primary location is Kenosha County, Wisconsin.
• Ability to travel (approximately 10%).
• Ability to work overtime as required.

This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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

$65,250 - $169,400

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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