Engineer - Quality - FUME

Job Details
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 serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
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 Lilly Kenosha County (LKC). This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.
The Engineer - Quality - FUME provides oversight, guidance and support in the area of Facilities, Utilities, Maintenance, and Equipment (FUME). This position is essential for maintaining GMP compliance and ensuring inspection readiness.
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.
• Leads, mentors, and coaches operations and support personnel on FUME quality matters.
• Acts as a QA SME, working with Global Facilities Delivery, Lilly project staff, Global Computer Systems QA, and selected service provider firms to complete the detailed design of the assigned areas employing QbD and Quality Risk Management (QRM) principles and ensuring the integration of Lilly Global Quality System requirements into the design and delivery of facilities, assets, and systems.
• Provides technical and quality review and approval of facility, utility, and equipment system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
• Provides quality oversight for the verification and qualification of facility, utility, and equipment systems including review of test cases, test execution, test summaries, and discrepancy resolution.
• Provides QA oversight of maintenance activities including initial calibrations and maintenance plan development.
• Provides mentorship and QA oversight for change management, QRM, process validation and equipment validation efforts.
• Works with the site quality to support the development of the vision and strategy for the overall site quality operation with focus on the FUME areas.
• Supports the site organization in building technical capability, for a diverse cross-functional staff in Quality, project teams, and area process teams, including mentoring of new Quality and other project staff.
• Fosters a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Leads project initiatives needed in support of site continuous improvement, site expansion, and the Quality function.
• Resolves or escalates any compliance issues to the project lead, site leadership, and Quality Management.
• Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site FUME systems including working as part of the site Utilities Process Team and Business Quality Assurance for local computer systems.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 3-5 years in the pharmaceutical industry with specific Quality FUME experience.
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Demonstrated solid knowledge in Change Management and Risk Assessment methodology
• Previous experience in GMP production environments.
• Previous experience with C&Q and Validation oversight including automation and computer systems validation
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Proficiency with applicable computer systems
• 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
• Technical Writing and Communication Skills
• CQE certification from the American Society for Quality (ASQ)
• Computer System Quality Assurance (CSQA) experience
• Previous use of KNEAT - or other electronic validation software
• Previous facility or area start up experience.
• Previous experience with GMP utilities including WFI, Clean Steam, Process Compressed Air.
• Previous experience with Maintenance systems.

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 ( ) 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.
#WeAreLilly
Company
Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.
Company info
Location 893 S Delaware St
Indianapolis
Indiana
46285
United States
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