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 35,000 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.
Position Brand Description: The Engineer - QA is responsible for providing technical guidance and leadership to the Indianapolis API Operations and Lilly Technology Center-S Utilities sites with regard to the quality standards employed to maintain and improve site operations. The area of focus is utilities but will require backup in facilities, systems and equipment management.
Key Objectives/Deliverables:
- Support manufacturing and provide coaching/feedback to engineering staff.
- Provide quality guidance and recommendations with regard to utility engineering and maintenance issues.
- Review and approval of engineering related documents (e.g., qualifications, change controls, deviations, validations).
- Review and approve applicable procedures.
- Maintain and improve Facility, utility, maintenance and equipment (FUME) quality systems.
- Write and review system and equipment periodic reviews, as appropriate.
- Participate in and/or lead self-inspection activities.
- Assist engineering staff and others in the interpretation of regulatory and corporate requirements.
Basic Requirements:
- BS in Engineering or a science-related field or equivalent experience.
Additional Preferences:
- Experience in API or finished product manufacturing, QA or Engineering.
- Experience with system and equipment qualifications.
- Knowledge of cGMPs, engineering standards and quality systems.
- Demonstrated strong written and verbal communications skills.
- Strong attention to detail.
- Understanding of statistical tools and analysis.
- Excellent interpersonal skills and networking skills.
- Ability to organize and prioritize multiple tasks.
- Demonstrated flexibility when faced with changing priorities.
- Proficiency with computer system applications and process automation systems.
Other Information:
- Must complete learning plan for Engineer - QA - IAPI/IFM.
- No certifications required.
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
- Must carry a cell phone to support 24 hour/day operations
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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
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