Quality Engineer Maintenance

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.
Organization Overview:
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss!
Responsibilities:
The Quality Engineer is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing areas at Lilly's new Concord, North Carolina site. The position will provide quality oversight for the startup and routine use of the Global Maintenance and Reliability System (GMARS.) This position will also assist with ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the Facilities, Utilities, Maintenance, and Equipment (FUME) quality system. This position may support the verification and delivery of the Automated Storage and Retrieval System (ASRS). Responsibilities include:

• Provide quality oversight for the startup and use of GMARS and Maintenance Strategies
• Provide quality oversight for the verification and qualification of facility, utility, and maintenance systems including review of test cases, test execution, discrepancy resolution, etc.
• Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals
• Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase
• Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures
• Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the FUME systems
• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Support the definition and execution of inspection readiness activities including support of site self-inspections by Global Quality
• Lead project initiatives in support of the project, drive Quality improvement factors, and general Quality function
• Resolve or escalate any compliance issues to the project, site, and Quality Management
• Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.

Basic Requirements:

• Previous experience with computerized maintenance systems
• Experience with FUME systems qualification including regulations governing them
• At least 5 years of experience in pharmaceutical QA
• Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
• Ability to work independently as a Quality SME with minimal supervision
• Proficiency with computer systems including GMARS, Trackwise, SAP etc.
• Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
• Ability to work 8-12 hour shifts onsite (not eligible for remote work)
• Ability to work overtime as required.
• Ability to travel for meetings and coordination with global teams including support of FAT's
• Position may require a short duration assignment up to 3 months to establish global contacts.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R3.

Education Requirements:

• Bachelors or equivalent degree in a scientific field

Additional Skills/Preferences:

• CQE Certified
• CSQA experience
• Previous use of KNEAT - or other electronic validation software
• Previous facility or area start up experience
• Technical aptitude and ability to train and mentor other

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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