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.
The Scientist - TS/MS - PAT will provide direct technical support to the process analytical equipment and ensure compliance with requirements within TSMS organization. She/He will be responsible to support the timely implementation and sustainability of Data Integrity requirements regarding the PAT equipment functionality, connectivity to Data Management System, MES integration, Data Mapping, Audit Trails, System Backup, Restoration, Disaster Recovery, Security, Business Continuity, CSV, Periodic Review, etc. She/He will have Administrator role for PAT equipment. She/He will support the integration between end-user's needs and implementation of changes or new technologies within PAT group as part of productivity agenda and responsible to develop and execute the computer system validation plan. She/He will be responsible to write, review and/or execute qualification protocols, computer system validation protocols, comparability studies, technical reports, deviations, change controls, procedures, methods, training material, data integrity risk assessments and any other applicable GMP document. She/he will provide technical support to PAT analytical equipment as part of day-to-day operation. Ensuring data integrity and verification procedures are followed. Maintain an effective collaboration with primary loop personnel, other functions, and other Lilly manufacturing sites to identify best practices for replication.
Basic Qualifications
Bachelor, Master or PhD Degree in Science (Chemistry, Analytical Chemistry, Industrial Biotechnology) or Engineering Discipline (Electrical, Chemical, Computer, Mechanical).
Proficient in data integrity program management, electronic tools, analytical equipment qualification and computer system validation.
Experience in supporting analytical equipment, analytical methods, computer systems and PAT technology preferable in the pharmaceutical industry.
1-4 years of experience with demonstrated examples of learning agility or 5-10 years of proven experience in similar position.
Salary commensurate with experience.
Other Requirements
Bilingual (English and Spanish).
Technical writing and presentation skills.
Teamwork oriented.
Self-started and demonstrate curiosity for searching and recommending improvements and new process analytical technology.
Strong compliance mindset and sound judgment.
Influence skill.
Demonstrated leadership skills.
Excellent communication skills, both oral and written.
Able to manage simultaneously several assigned tasks.
Flexibility is required to support site needs outside regular business hours including weekends as required.
Excellent interpersonal skills that promote engagement and teamwork within cross-functional environment.
Important Notice:
In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.
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 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.
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.
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