Quality Assurance Engineer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

• Ensure that quality systems directly related to facilities, utilities, maintenance, and equipment are managed in accordance with established quality standards.
• Ensure that facilities, utilities, factory equipment, and Quality Control Laboratory equipment, both with and without automation and distributed control systems, are maintained in a validated state throughout their entire life cycle by participating in monitoring processes, periodic reviews, and changes to them.
• Collaborate in maintaining the validation/qualification status of equipment and packaging processes, either through change controls as they occur or through the monitoring activities established in the periodic review strategy.
• Participate in project management teams and in their validations/qualifications to ensure they are carried out in accordance with the requirements established by the Corporation for facilities, equipment, and utilities.
• Approve periodic reviews or monitoring reports of the qualification status of equipment, facilities, and utilities to guarantee their continuous improvement.
• Provide technical and quality advice to the Maintenance and Engineering areas to achieve continuous improvement and ensure functional excellence.
• Ensure that preventive and corrective maintenance is properly performed and documented to guarantee the stability of the maintenance program.
• Perform monitoring of utilities to ensure compliance with specifications and perform periodic evaluations of them, as well as the investigation of any deviations that arise in said utilities.
• Approve the plant's GMP documents to ensure they comply with predetermined standards, for example: procedures, specifications, validations, qualification protocols, reports, etc.
• Participate in audits conducted by Health Authorities, the Corporation, or Third Parties when applicable.

Minimum of 4 years of experience in manufacturing and quality areas within a highly regulated industry.

Experience in the pharmaceutical industry as well as experience in qualification and validation processes will be positively valued

• Interpersonal skills: teamwork, customer orientation (internal/external), decision-making, good oral and written communication.
• Organizational skills: ability to prioritize objectives, highly organized and detail-oriented individuals.
• Technical skills: knowledge of Good Manufacturing Practices, quality concepts and their application in the pharmaceutical industry, as well as staying informed about new trends in facilities and utilities and their application in the Pharmaceutical Industry.
• Proficiency in IT tools: knowledge of commonly used office software at a user level, as well as knowledge of the computer systems that control business processes.

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 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.

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

$ - $

Full-time equivalent employees may also 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 pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) 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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