CSV Engineer - Automation Engineering

Biopharma Careers; Lebanon (KY); On-site; USD 66,000 - 172,000; Full time

Job summary

Lilly is building a new Medicines Foundry in Lebanon, Indiana, with initial work in Carmel, IN. The Automation Engineering role provides CSV support for process control systems across the site and participates in validating DCS, SCADA, BMS, MES, and related platforms.

You will work with cross-functional teams to ensure compliant, validated automation solutions for GMP manufacturing. Responsibilities include developing validation plans, executing protocols, maintaining documentation, and

Qualifications

• Bachelor's degree in engineering; 2+ years in FDA-regulated environments.
• Experience with design, development, commissioning or qualification of computer systems.
• Authorized to work in the United States on a full-time basis; no visa sponsorship.

Responsibilities

• Process control validation testing, implementation and coordination.
• Develop and implement the Automation Engineering Project Validation Plan.
• Provide SME for computer system validation and data integrity for automation systems across the site.
• Perform risk assessments for computerized systems and develop mitigation strategies.
• Develop and Execute validation protocols for computerized systems.
• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity).
• Generate and maintain validation documentation (plans and summaries).
• Develop local site procedures related to automation systems.
• Manage change control and deviation management for CSV activities.
• Collaborate with vendors to ensure third-party systems meet validation requirements.

Skills

Automation engineering

CSV validation

GMP compliance

Regulatory (21 CFR Part 11)

Education

Bachelor of Science in Engineering

Tools

DeltaV

Rockwell

Syncade

LabVantage

OSI PI

Kneat

ALM

Valgenesis

Job description

Overview

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.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

This role 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 Engineer is also responsible for ensuring that reliable and compliant control applications and systems are in place and maintained to support manufacturing operations at the Foundry. Additionally the Engineer serves as a key technical expert, partnering across the Automation Engineering organization and other functional disciplines to influence and implement 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 a full scale GMP manufacturing through start up

Responsibilities

• 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 etc) 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 document 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 leveraging 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 or similar degree (Ph.D's will not be considered at this level).
• 2+ years working experience in FDA regulated environments
• Experience with design, development, commissioning, or qualification of computer systems
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• Deep knowledge of GMP/GXP, regulatory requirements, computer system validation and data integrity
• Experience in Automation Engineering, preferably in major pharmaceutical manufacturing
• 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.

Initial location in Carmel, IN

Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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 (AMECA)
• Black Employees at Lilly (BE@Lilly)
• Chinese Culture Network (CCN)
• EnAble
• Evolve
• Lilly Indian Network (LIN)
• Organization of Latinx at Lilly (OLA)
• Pride (LGBTQ+ Allies)
• Veterans Leadership Network (VLN)
• Women’s Initiative for Leading at Lilly (WILL)

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

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.