CSV Automation Engineer (R3)

Eli Lilly and Company seeks a CSV Automation Engineer (R3) to lead qualification and requalification activities for CSV (computerized systems validation) for automated process control equipment and computerized systems.

Implement new systems, system upgrades, and system modifications.

Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes.

Develop and implement computer systems/automation validation policies.

Maintain validation master plans and ensure that activities are compliance to current regulations.

#LI-DNI Position requires a Bachelor’s degree in Computer Engineering, Mechanical Engineering, Chemical Engineering or a related engineering field and 4 years of experience performing qualifications of manufacturing automated equipment and computerized systems.

Experience must include a minimum of: 4 years of experience with automated process equipment or utility systems to develop qualification protocols; 4 years of experience with applying data integrity principles to ensure the alignment of testing strategies and use of electronic data and databases; 4 years of experience developing and executing CSV documentation supporting the manufacturing automated systems; 4 years of experience with supporting validation according to FDA or EU regulations; 4 years of experience coordinating projects and directing team members; and 4 years of experience in performing periodic review (Asset Qualification Monitoring) on computerized system of equipment and area for confirming it stayed in compliance.

#LI-DNI Job location: Branchburg, NJ.

To apply, please visit and enter job requisition number R-82406 when prompted.

Alternatively, please send your resume, cover letter, and a copy of the ad to: Beth L.

Berry, Lilly Corporate Center, Indianapolis, IN 46285.

Full Time