Eli Lilly and Company
Senior Principal Engineer - Automation Engineering – CSV
Eli Lilly and Company, Lebanon, Indiana, United States, 46052
Overview
Be among the first 25 applicants. 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 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’re looking for people who are determined to make life better for people around the world.
Senior Principal Engineer - Automation Engineering The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will collaborate with cross-functional teams, providing expertise in validating systems critical to the manufacture of life-changing products at the new site.
The Senior Principal Engineer is responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in manufacturing at Foundry. Additionally, this role serves as a key technical expert with partners to influence and implement within the Automation Engineering organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.
In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to full-scale GMP manufacturing through start up.
Responsibilities
Technical Leadership
Mentor process control team, including design, controls philosophy, implementation and commissioning
Process control validation testing, implementation and coordination
Develop and implement the Automation Engineering Project Validation Plan
Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including:
Process Automation Systems (DCS, SCADA, BMS, MES, Historian)
Building Management System
Vendor Packaged Equipment
Data Historian
Automated Storage and Retrieval System
QMS
Perform risk assessments for computerized systems and develop strategies to mitigate identified risks
Develop and execute validation protocols for computerized systems
Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity, etc) and Lilly quality policies and procedures
Generate and maintain validation documentation (validation plans and summary reports)
Develop local site procedures related to automation systems (e.g., SOPs, Work Instructions)
Manage change control and deviation management as it pertains to CSV activities
Collaborate with vendors to ensure third-party systems and software meet validation requirements; conduct vendor audits as needed
Provide training to personnel on CSV principles, procedures and best practices
Stay informed of industry trends and advancements in CSV and automation technologies
Represent the automation department during audits by regulatory agencies as assigned
Act as functional owner for the Electronic testing system (Kneat, ALM, Valgenesis) managing CSV documents relating to automation systems
Operational Excellence
Review and oversee design documentation including Functional Requirements, Design Specifications, DCS Application Software, and Test Specifications
Lead/participate in design reviews and automation application software reviews to ensure compliance and standardization
Provide periodic status updates to Project Management
Devise CSV and quality strategies for control systems in collaboration with Site Quality organization
Implement and support electronic systems (such as plant historians) used to capture process automation related production data
Maintain the validated state of site control systems in line with Lilly quality standards, including development and execution of validation strategies and documentation
Provide automation support for capital projects including new product introductions
Promote the use of automation to improve productivity, operational efficiency and compliance
Develop a network of corporate contacts and leverage corporate expertise when needed
Organizational Capability
Set and reinforce standards for appropriate rigor in automation work products in coordination with automation and compliance consultants
Demonstrated initiative, planning and organizational skills, ability to prioritize tasks and meet timelines
Strong problem-solving skills and desire for continuous improvement
Ability to influence peers and business partners
Good written and verbal communication skills for both technical and non-technical audiences
Knowledge of GMP, regulatory requirements, and computer system validation
Basic Requirements
Minimum B.S. in Engineering with experience in Automation Engineering, preferably in major pharmaceutical manufacturing with system integration of applications, systems and platforms
8+ years working experience in Biopharma engineering, operations, or manufacturing
Knowledge of GMP, regulatory requirements, computer system validation and data integrity
Experience with highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI)
Experience in commissioning, qualifying and supporting systems for interconnectivity between SCADA, DCS, MES, LIMS, Historian and other applications
Experience in design, development, commissioning and qualification activities ensuring quality compliance and data integrity
Experience in facilitating and driving decision-making at an organizational level
About accommodations and equal opportunity Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form at care ers.lilly.com/us/en/workplace-accommodation for further assistance. Lilly is 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.
Additional information 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 employees are eligible for a company bonus, and Lilly offers a comprehensive benefits program including 401(k), health/dental/vision, flexible spending accounts, life insurance, paid time off, and well-being benefits. Lilly reserves the right to amend compensation and benefit programs. #WeAreLilly
#J-18808-Ljbffr
Senior Principal Engineer - Automation Engineering The Senior Principal Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will collaborate with cross-functional teams, providing expertise in validating systems critical to the manufacture of life-changing products at the new site.
The Senior Principal Engineer is responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in manufacturing at Foundry. Additionally, this role serves as a key technical expert with partners to influence and implement within the Automation Engineering organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.
In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to full-scale GMP manufacturing through start up.
Responsibilities
Technical Leadership
Mentor process control team, including design, controls philosophy, implementation and commissioning
Process control validation testing, implementation and coordination
Develop and implement the Automation Engineering Project Validation Plan
Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including:
Process Automation Systems (DCS, SCADA, BMS, MES, Historian)
Building Management System
Vendor Packaged Equipment
Data Historian
Automated Storage and Retrieval System
QMS
Perform risk assessments for computerized systems and develop strategies to mitigate identified risks
Develop and execute validation protocols for computerized systems
Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity, etc) and Lilly quality policies and procedures
Generate and maintain validation documentation (validation plans and summary reports)
Develop local site procedures related to automation systems (e.g., SOPs, Work Instructions)
Manage change control and deviation management as it pertains to CSV activities
Collaborate with vendors to ensure third-party systems and software meet validation requirements; conduct vendor audits as needed
Provide training to personnel on CSV principles, procedures and best practices
Stay informed of industry trends and advancements in CSV and automation technologies
Represent the automation department during audits by regulatory agencies as assigned
Act as functional owner for the Electronic testing system (Kneat, ALM, Valgenesis) managing CSV documents relating to automation systems
Operational Excellence
Review and oversee design documentation including Functional Requirements, Design Specifications, DCS Application Software, and Test Specifications
Lead/participate in design reviews and automation application software reviews to ensure compliance and standardization
Provide periodic status updates to Project Management
Devise CSV and quality strategies for control systems in collaboration with Site Quality organization
Implement and support electronic systems (such as plant historians) used to capture process automation related production data
Maintain the validated state of site control systems in line with Lilly quality standards, including development and execution of validation strategies and documentation
Provide automation support for capital projects including new product introductions
Promote the use of automation to improve productivity, operational efficiency and compliance
Develop a network of corporate contacts and leverage corporate expertise when needed
Organizational Capability
Set and reinforce standards for appropriate rigor in automation work products in coordination with automation and compliance consultants
Demonstrated initiative, planning and organizational skills, ability to prioritize tasks and meet timelines
Strong problem-solving skills and desire for continuous improvement
Ability to influence peers and business partners
Good written and verbal communication skills for both technical and non-technical audiences
Knowledge of GMP, regulatory requirements, and computer system validation
Basic Requirements
Minimum B.S. in Engineering with experience in Automation Engineering, preferably in major pharmaceutical manufacturing with system integration of applications, systems and platforms
8+ years working experience in Biopharma engineering, operations, or manufacturing
Knowledge of GMP, regulatory requirements, computer system validation and data integrity
Experience with highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI)
Experience in commissioning, qualifying and supporting systems for interconnectivity between SCADA, DCS, MES, LIMS, Historian and other applications
Experience in design, development, commissioning and qualification activities ensuring quality compliance and data integrity
Experience in facilitating and driving decision-making at an organizational level
About accommodations and equal opportunity Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form at care ers.lilly.com/us/en/workplace-accommodation for further assistance. Lilly is 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.
Additional information 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 employees are eligible for a company bonus, and Lilly offers a comprehensive benefits program including 401(k), health/dental/vision, flexible spending accounts, life insurance, paid time off, and well-being benefits. Lilly reserves the right to amend compensation and benefit programs. #WeAreLilly
#J-18808-Ljbffr