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Lilly Validation Engineer in Branchburg, New Jersey

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 the development and execution of qualification protocols and reports, ensuring qualification and validation activities meet internal and external compliance requirements, effectively managing projects to deliver on time, and coordinating validation activities with the appropriate functional groups. This position will support cleaning and shipping qualification activities and interact with Process Teams, TS/MS, Manufacturing, Logistics, Warehouse, Engineering, Quality, and other Lilly site SMEs.

PRIMARY RESPONSIBILITIES:

  • Develop and execute technical documents (PQ protocols and reports) using a risk-based approach for biopharmaceutical manufacturing equipment specifically related to cleaning validation and shipping qualification.

  • Develop and/or update validation SOPs and Policies.

  • Perform cleaning validation/verification sampling, submit samples using laboratory management system and analyze results. Document GMP activities using ALCOA+ principles.

  • Perform shipping qualification, analyze temperature monitor data, and document GMP activities using ALCOA+ principles.

  • Prioritize validation activities. Communicate and document status to management and appropriate departments such as Manufacturing, Quality Assurance, and the Quality Control laboratories.

  • Represent department as subject matter expert (SME) presenting validation activities during regulatory inspections.

  • Use effective project management skills to manage multiple activities and ensure on-time project delivery.

  • Provide technical evaluations and expertise of complex validation issues, support discrepancy investigations, deviations, and root cause analysis 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 of 2 to 5 years experience in qualification/validation of typical GMP utilities and/or process equipment in a pharmaceutical/ biopharmaceutical facility.

ADDITIONAL SKILLS AND PREFERENCES:

  • Knowledge of cell culture, purification and drug substance shipping in the manufacturing of biotech products is preferred.

  • 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.

  • Proficient in MS Office (Word, Excel, Project, Outlook, etc.).

  • Experience with the following applications/systems is a plus: TrackWise, Records Management Systems, LIMS.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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