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Sr. Quality Engineer

Carolina, Puerto Rico

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Req ID R-9987 Title Sr. Quality Engineer City CAROLINA Country Puerto Rico

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 39,000 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.

Job Responsibilities

To provide technical guidance, compliance expertise and leadership with regard to the quality standards to maintain and improve site operations; to define, design, implement, qualify and start-up assets (equipment/facilities) and utilities/processes; quality systems and GMP compliance.

The Senior QA Engineer’s position is essential for maintaining GMP compliance, Data Integrity, quality systems, training other personnel in the department, and in the preparation for Pre-Approval and General Inspections by various regulatory agencies.

Basic Qualifications

Bachelor Degree in Chemical Engineering; Biotechnical Engineering; Biomedical Engineering; Mechanical Engineering; or related is required.

At least five (5) years of experience in an engineering or technically related role in automated bulk pharmaceutical GMP operations (Production, Engineering, QA or Technical Services) with thorough understanding of utilities and maintenance, Commissioning and Qualification and understanding of Quality Systems is required.

License Requirement

P.E. or E.I.T. license and member of CIAPR

Additional Skills/Preferences

Fully bilingual (English/Spanish) written and verbal communication. Computer literate, teamwork oriented, strong communication skills and the ability to collaborate with other parts of the organization and across multiple levels to influence and drive results. Consistent self initiative to resolve discrepancies, establish strategies and create systems to ensure adherence to compliance and expectations.  Good organizational skills and ability to prioritize tasks. Flexibility is required to support site needs outside regular business hours including weekends as required.

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.

Lilly is an EEO/Affirmative Action Employer and 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-9987.

Lilly is an EEO/Affirmative Action Employer and 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.

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