CSV Automation Engineer (R3)
Apply NowCompany: Eli Lilly
Location: Readington, NJ 08870
Description:
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 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.
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 https://jobsearch.lilly.com/ 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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$143,354
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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 https://jobsearch.lilly.com/ 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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$143,354
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly