Eli Lilly And Company
Validation Engineer - Technical Services (Finance)
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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
GENERAL SUMMARY:
This position requires knowledge of cGMPs, excellent technical writing, and problem-solving skills. Responsibilities include but are not limited to: development and execution of cleaning validation protocols, verification and monitoring activities, preparation and routing of validation reports, ensuring qualification and validation activities meet internal and external compliance requirements, effectively manage projects to deliver on time and consistent results, and interaction with Process Teams, Tech Services/Manufacturing Services, Manufacturing, Engineering, Quality, and other Lilly site SMEs.
PRIMARY RESPONSIBILITIES:
Develop and execute technical documents (Performance Qualifications protocols and reports) using a risk-based approach for biopharmaceutical manufacturing equipment specifically related to cleaning validation.
Perform cleaning validation/verification sampling, submit samples using laboratory management system and analyze results. Document GMP activities using ALCOA+ principles.
Perform cleaning monitoring sampling in accordance with approved monitoring schedule and analyze Clean in Place (CIP) trends using the Historian CIP dashboard.
Communicate status of validation activities to Validation Technical Services (VTS) management, Manufacturing, Quality Assurance, and the Quality Control laboratories.
Use effective project management skills to manage multiple activities and ensure on-time project delivery.
Provide technical evaluations and expertise of complex validation issues supporting discrepancy investigations, deviations and develop corrective action plans, as required.
Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes.
Flexibility to occasionally work off-hours to accommodate Manufacturing schedule.
REQUIRED KNOWLEDGE, SKILLS & EDUCATION:
Bachelor's degree in Engineering, Science, or related discipline.
Minimum 2 - 5 years experience in cleaning validation in a pharmaceutical/biopharmaceutical facility.
Knowledge of validation lifecycle approach and FDA/international regulatory requirements.
Ability to work with others in a fast-paced environment.
Must have strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner.
Proficient in good documentation practices and GMP principals working in a GMP environment.
Strong analytical, problem solving, and excellent interpersonal skills.
Knowledge of cell culture, purification and support systems, and its associated bioprocessing equipment used in the manufacturing of biotech products is preferred.
Proficient in MS Office (Word, Excel, Project, Outlook, etc.).
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.