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Engineer-Validation Technical Services FDE

Engineer-Validation Technical Services FDE
Branchburg Park
New Jersey
United States
North America
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.
This validation engineer position requires knowledge of cGMPs, excellent technical writing, and problem solving skills. Responsibilities will include but not limited to: 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 Installation Qualification (IQ), Operational (OQ), Performance Qualification (PQ) protocols 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 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.
  • Bachelor’s degree in Engineering, Computer Science, Science, or related discipline.
  • Minimum 3 years pharmaceutical/biopharmaceutical validation experience
  • 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.
  • Must have understanding of Multiproduct Manufacturing.
  • Must have an understanding of ASTM E2500.
  • Understanding of chromatography and TFF Skids is a plus.
  • Understanding of FDA and EU regulations and guidelines and knowledgable of current industry trends.
  • 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 within a GMP environment.
  • Strong analytical, problem solving, and excellent interpersonal skills.
  • Proficient in MS Office (Word, Excel, Project, Outlook, etc.).
  • This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
  • 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.