What are the responsibilities and job description for the Principal Engineer CSV and Data Integrity position at BioSpace?
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.
Organization Overview
Digital Manufacturing Engineering (DME) is part of the Corporate Engineering Tech Center (ETC). The ETC is a technical resource for training, standards, project implementation, and the center of engineering excellence for the corporation, providing deeply technical resources to solve the most intractable technical problems in manufacturing. DME provides OT data integration solutions, engineering data standardization/ownership, digital manufacturing solutions, and leads OT Data Integrity and Cyber Security initiatives and standards globally for Lilly Manufacturing. Our team focuses on connecting our facilities (securely) and leveraging the data from those facilities to deliver digital manufacturing solutions to improve manufacturing productivity, data integrity / compliance, quality, and operational excellence. Digital Manufacturing Technologies include digital twins, computational modeling, edge/IoT, and analytics solutions.
Position Description And Responsibilities
The Engineer – Computer System Validation and Data Integrity is an Engineering role will be the corporate engineering Computer System Validation/Data Integrity lead and will support Lilly facilities globally working closely and collaboratively with MQ-Tech@Lilly and Global Quality. The position requires a high learning agility and experience in one or more process automation systems with a strong focus on data, systems integration, Commissioning and Qualification (C&Q) methods, architecture, and supporting automation platforms.
This role will require a strong understanding of automation/computer system validation practices and industry/regulatory knowledge in Data Integrity and Lilly Quality Systems. The role will also support automation teams' delivery in capital projects and provide guidance on automation/computer system testing and Data Integrity Assessments.
Key Objectives/Deliverables
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
$64,500 - $167,200
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
Organization Overview
Digital Manufacturing Engineering (DME) is part of the Corporate Engineering Tech Center (ETC). The ETC is a technical resource for training, standards, project implementation, and the center of engineering excellence for the corporation, providing deeply technical resources to solve the most intractable technical problems in manufacturing. DME provides OT data integration solutions, engineering data standardization/ownership, digital manufacturing solutions, and leads OT Data Integrity and Cyber Security initiatives and standards globally for Lilly Manufacturing. Our team focuses on connecting our facilities (securely) and leveraging the data from those facilities to deliver digital manufacturing solutions to improve manufacturing productivity, data integrity / compliance, quality, and operational excellence. Digital Manufacturing Technologies include digital twins, computational modeling, edge/IoT, and analytics solutions.
Position Description And Responsibilities
The Engineer – Computer System Validation and Data Integrity is an Engineering role will be the corporate engineering Computer System Validation/Data Integrity lead and will support Lilly facilities globally working closely and collaboratively with MQ-Tech@Lilly and Global Quality. The position requires a high learning agility and experience in one or more process automation systems with a strong focus on data, systems integration, Commissioning and Qualification (C&Q) methods, architecture, and supporting automation platforms.
This role will require a strong understanding of automation/computer system validation practices and industry/regulatory knowledge in Data Integrity and Lilly Quality Systems. The role will also support automation teams' delivery in capital projects and provide guidance on automation/computer system testing and Data Integrity Assessments.
Key Objectives/Deliverables
- Work safely and continuously look for improvements to both people and equipment safety.
- Provide corporate engineering leadership to Data Integrity programs, new asset DI assessments, and develop best practices and standards to support manufacturing and major capital project delivery.
- Provide Process Automation reviews and influence Global Quality Procedures that impact computer systems and automation platforms.
- Develop and lead a community of practice for our manufacturing sites for Data Integrity and CSV programs.
- Develop templates and standards for Verification (formerly known as Commissioning and Qualification).
- Innovation - Evaluate new technologies for Verification such as electronic testing systems.
- Support Major Capital Projects in setting up Computer System Validation strategies for automation systems.
- Provide quality oversight to central solutions and libraries.
- Own Global Engineering Best Practices for Manufacturing on Data Integrity Information Classification
- Lead / Facilitate Automation Quality Team.
- Bachelor of Science Degree in engineering or a related science field
- 3 years of experience in process automation engineering supporting a manufacturing site, with demonstrated work and/or training in one or more process automation platforms
- Experience working in a regulated industry
- B.S. preferably in Chemical, Mechanical, Electrical, or Computer Engineering
- Experience in pharma or GMP industry
- Experience in commissioning and qualification
- Experience working with validated systems
- Expertise in Lilly’s preferred platforms, including Rockwell Automation, Emerson DeltaV, Foxboro, and Microsoft Operating Systems
- Ability to work well with different cultures and engineering disciplines internationally
- Knowledge in Historians, and IT platforms such as servers, and workstations
- Monday through Friday Day Shift of 7:30am-4:30pm with some allowance for flex time.
- This is NOT a remote position and requires onsite presence
- Limited Domestic and International travel required (less than 10%)
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
$64,500 - $167,200
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
Salary : $64,500 - $167,200
