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As a validation engineer you will be responsible for the development and execution of computer system qualification protocols, ensuring qualification and validation activities meet internal and external compliance requirements, effectively manage projects to deliver on time and consistent results, and coordinating validation activities with the appropriate functional groups.
Develop and execute technical documents (e.g. Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report) using a risk based approach for biopharmaceutical manufacturing equipment specifically related to computerized support systems (PLC, HMI, etc).
Prioritize validation activities. Communicate and document status to management and appropriate departments.
Use effective project management skills to manage multiple activities and ensure on-time project delivery.
Provide technical evaluations of complex validation issues supporting discrepancy investigations 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
Have understanding of:
Chromatography and TFF Skids in a multiproduct manufacturing environment.
Experience with the following applications/systems: Wonderware/OSI-PI (or other similar systems), WinCC, Allen Bradley PLCs/equipment (RSView, PanelView, RSLogix), ladder logic.
Knowledge of validation lifecycle approach and FDA/international regulatory requirements.
Ability to work with others in a fast-paced environment.
Strong analytical, problem solving, and excellent interpersonal skills.
Proficient in MS Office (Word, Excel, Project, Outlook, etc.).
Strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner within a GMP environment.
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.
Bachelors degree in Engineering, Computer Science, Science, or related discipline.
Minimum 3 years with validation of typical GMP manufacturing computer systems in a pharmaceutical/biopharmaceutical facility.
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
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe 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.
We strive to make life better and to be leaders in diversity and inclusion, clinical research, corporate responsibility and employee benefits. For more than 140 years, we have received recognition from several distinguished organizations for our efforts. Here are some of our 2019 honors:
Catalyst Award, for our innovative Employee Journeys and People Strategy
Corporate Knights, Global 100 Most Sustainable Corporations in the World
Ethisphere, World's Most Ethical Companies
Forbes, America's Best Employers for Diversity
Forbes, America's Best Large Employers
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