BioSpace
Senior Principal Engineer - Automation Engineering – CSV
BioSpace, Lebanon, Indiana, United States, 46052
Overview
3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. 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.
Key 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 corporate 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 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
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 and comprehensive benefits as described in the original posting.
#WeAreLilly
#J-18808-Ljbffr
3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. 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.
Key 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 corporate 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 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
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 and comprehensive benefits as described in the original posting.
#WeAreLilly
#J-18808-Ljbffr