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.
If you are talented scientist interested in working for the company awarded “top five” by Science Magazine’s “Top Twenty Employers,” read on:
This position requires an individual with a thorough knowledge of all aspects of biopharmaceutical validation, compliance regulations, and excellent technical writing and problem solving skills. Responsibilities will include the following: coordinate validation project activities, develop and execute equipment qualification protocols, change control, and revalidation. Previous experience with environmental monitoring qualification and temperature mapping is recommended. Must have the ability to integrate differing solutions into a cohesive and well-structured quality plan. Using effective project management skills, must deliver projects on time and within budget.
Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.
• Develop and execute Installation, Operational and Performance Qualification protocols for biopharmaceutical manufacturing utilities, facilities (classified rooms), warehouse and environmentally controlled chambers.
• Provide technical evaluations of complex validation issues supporting discrepancy investigations and change controls; develop corrective action plans, as required
• Prioritize validation activities. Communicate and document status to management and appropriate departments
• Review change controls and assess changes that affect qualified systems.
• Implement a team approach for validation activities with internal departments (i.e., facilities, manufacturing and quality control) and other Lilly sites
• Use effective project management and leadership skills to supervise validation project teams. Have appropriate knowledge of schedule, budget, and scope. Prepare agendas, issue meeting minutes and participate in development of quality execution plans
• Coordinate qualification activities with appropriate departments.
• Operate and maintain data acquisition systems and validation testing instruments including Kaye Validator and wireless data loggers.
• Evaluate and perform requalification activities
Basic Qualifications 1.Bachelor’s degree in Engineering or in a scientific discipline
2.Minimum 2-5 years utilities engineering validation experience (e.g. HVAC validation, pharmecutical industry, FDA regulated validation)
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Skills/Preferences •Thorough understanding of cGMPs and all compliance regulations
• Ability to work effectively with others in a fast-paced environment.
• Ability to effectively communicate technical information in a clear, concise manner within a GMP-regulated environment
• Ability to effectively manage multiple projects simultaneously
• Proficient in MS Office (Word, Excel, Outlook, etc.)
Additional Information 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.