BioSpace
Senior Principal Engineer - Automation Engineering – CSV
BioSpace, Lebanon, Indiana, United States, 46052
Senior Principal Engineer - Automation Engineering – CSV
BioSpace
is hiring for a senior principal engineer in the Automation Engineering Department at Eli Lilly’s Foundry. The engineer will provide automation support for multiple operating areas, lead and execute CSV activities for process automation systems across the site, and collaborate with cross‑functional teams to validate systems critical to the manufacture of life‑changing products.
Key Objectives/Deliverables
Technical Leadership
Mentor the 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, such as validation plans and summary reports
Develop local site procedures (e.g., SOPs, Work Instructions) related to automation systems
Manage change control and deviation management as it pertains to CSV activities
Collaborate with vendors to ensure that 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 (e.g., CSA) 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 the design documentation including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications and execution
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 the site control systems in line with Lilly quality standards, including the development and execution of validation strategies and associated documentation
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
In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products
Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines
Possess a keen technical curiosity and has demonstrated strong problem‑solving skills and a desire for continuous improvement
Demonstrated 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, computer system validation
Basic Requirements
Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling system integration of applications, systems and platforms
8+ years of working experience in Biopharma engineering, operations, or manufacturing
Knowledge of GMP, regulatory requirements, computer system validation
Deep knowledge of GMP, regulatory requirements, computer system validation and data integrity
Experience in design, development, commissioning and qualification of 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 between SCADA, DCS, MES, LIMS, Historian and other applications for interconnectivity
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
Compensation and Benefits Salary range: $64,500 – $167,200 per year. Full‑time employees are eligible for company bonus, 401(k), pension, vacation, medical, dental, vision, prescription drug benefits, flexible spending accounts, life insurance, and various well‑being benefits.
EEO Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. 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. 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.
#J-18808-Ljbffr
is hiring for a senior principal engineer in the Automation Engineering Department at Eli Lilly’s Foundry. The engineer will provide automation support for multiple operating areas, lead and execute CSV activities for process automation systems across the site, and collaborate with cross‑functional teams to validate systems critical to the manufacture of life‑changing products.
Key Objectives/Deliverables
Technical Leadership
Mentor the 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, such as validation plans and summary reports
Develop local site procedures (e.g., SOPs, Work Instructions) related to automation systems
Manage change control and deviation management as it pertains to CSV activities
Collaborate with vendors to ensure that 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 (e.g., CSA) 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 the design documentation including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications and execution
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 the site control systems in line with Lilly quality standards, including the development and execution of validation strategies and associated documentation
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
In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products
Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines
Possess a keen technical curiosity and has demonstrated strong problem‑solving skills and a desire for continuous improvement
Demonstrated 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, computer system validation
Basic Requirements
Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling system integration of applications, systems and platforms
8+ years of working experience in Biopharma engineering, operations, or manufacturing
Knowledge of GMP, regulatory requirements, computer system validation
Deep knowledge of GMP, regulatory requirements, computer system validation and data integrity
Experience in design, development, commissioning and qualification of 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 between SCADA, DCS, MES, LIMS, Historian and other applications for interconnectivity
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
Compensation and Benefits Salary range: $64,500 – $167,200 per year. Full‑time employees are eligible for company bonus, 401(k), pension, vacation, medical, dental, vision, prescription drug benefits, flexible spending accounts, life insurance, and various well‑being benefits.
EEO Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. 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. 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.
#J-18808-Ljbffr