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Lilly Computer System 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.

Organization Overview:

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.

Position Description:

This position requires knowledge of cGMPs, excellent technical writing, and problem-solving skills. Responsibilities will include but not limited to: development and execution of installation, operational, and performance qualification protocols and reports, 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.

Responsibilities:

Manage for Results/Strategic Planning:

  • Develop and execute qualification and validation documents using a risk-based approach for biopharmaceutical manufacturing equipment and supporting systems

  • Participate/facilitate in design reviews to ensure design meets user requirements

  • Develop and/or update validation SOPs and Policies, 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/deviation 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

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

  • Understanding of key Data Integrity principles (ALCOA+) to ensure requirements are aligned to appropriate testing strategies

Basic Requirements:

  • Bachelor’s degree in Engineering, Computer Science, Science, or related discipline

  • Minimum of 0 to 5 years of experience in qualification/validation of typical GMP utilities, facilities, computer systems and/or process equipment in a pharmaceutical/biopharmaceutical facility

Computer Systems Validation:

  • Develop and execute Computer Systems Validation documentation such as Validation plan, qualification strategies and risk assessment, URS, FRS, Traceability Matrices, BCPs, commissioning and IQ/OQ/PQ protocols and reports

  • Experience with the following automation applications/systems is a plus: OSI-PI (or other similar systems), Allen Bradley PLCs/equipment (RSView, Factory Talk View, PanelView, RSLogix), ladder logic, as applicable

  • Understanding of key Data Integrity principles to ensure the use of electronically captured data / databases

  • Previous experience/knowledge with S88 batch control is plus

Additional Preferences:

  • 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 within 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, Maximo, LIMS

Additional Information:

  • Travel not required

  • Lifting required (NMT 50 lbs.)

  • Occasional off hours work to accommodate manufacturing schedule

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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