Lilly Sr. Quality Engineer in Carolina, 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.
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.
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.
P.E. or E.I.T. license and member of CIAPR
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.
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!