Senior Principal Engineer - Automation Engineering – CSV at Eli Lilly and Company

Lebanon, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in computer system validation (CSV) and data integrity for automation systems including Process Automation Systems (DCS, SCADA, BMS, MES, Historian), Building Management System, Vendor Packaged Equipment, Data Historian, Automated Storage and Retrieval System, QMS
Ability to perform risk assessments for computerized systems and develop mitigation strategies
Experience developing and executing validation protocols for computerized systems
Knowledge of regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity) and corporate quality policies
Capability to generate and maintain validation documentation (validation plans, summary reports)
Skills in developing local site procedures (SOPs, Work Instructions) related to automation systems
Proficiency in managing change control and deviation management for CSV activities
Experience collaborating with vendors, ensuring third-party systems meet validation requirements, and conducting vendor audits
Ability to provide training on CSV principles, procedures, and best practices
Awareness of industry trends (e.g., CSA) and advancements in CSV and automation technologies
Experience representing the department during regulatory audits
Capability to act as functional owner for Electronic testing systems (Kneat, ALM, Valgenesis) managing CSV documents
Technical leadership in mentoring process control teams on design, controls philosophy, implementation, and commissioning
Experience in process control validation testing, implementation, and coordination
Ability to develop and implement Automation Engineering Project Validation Plans
Skills in reviewing and overseeing design documentation including Function (incomplete in JD, but implied)

Responsibilities

Provide automation support for operating areas across site and/or capital projects
Lead and execute CSV activities for process automation systems across the site
Collaborate with cross-functional teams, providing expertise in validating systems critical to manufacturing
Ensure productivity and mentorship of employees for reliable and compliant control applications and systems
Act as key technical expert to influence and implement within Automation Engineering and across functional disciplines to support process control agenda, business priorities, and compliance
Mentor process control team, including design, controls philosophy, implementation, and commissioning
Coordinate process control validation testing, implementation, and coordination
Develop and implement the Automation Engineering Project Validation Plan
Provide subject matter expertise for CSV and data integrity across specified automation systems
Perform risk assessments for computerized systems and develop strategies to mitigate risks
Develop and execute validation protocols for computerized systems
Ensure compliance with regulatory requirements, industry standards, and corporate quality policies
Generate and maintain validation documentation such as plans and summary reports
Develop local site procedures (e.g., SOPs, Work Instructions) related to automation systems
Manage change control and deviation management pertaining 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 (e.g., CSA) and advancements in CSV and automation technologies
Represent the automation department during audits by regulatory agencies
Act as functional owner for Electronic testing system (Kneat, ALM, Valgenesis) managing CSV documents related to automation systems
Review and oversee Design documentation including Function (incomplete in JD, but implied responsibility)

Skills

Key technologies and capabilities for this role

CSVAutomation EngineeringProcess AutomationControl SystemsGMPComputer System ValidationValidation

Questions & Answers

Common questions about this position

What is the work location for this Senior Principal Engineer role?

This information is not specified in the job description.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What key skills and expertise are required for this role?

The role requires expertise in computer system validation (CSV), process control validation testing, risk assessments for computerized systems, developing and executing validation protocols, and knowledge of systems like DCS, SCADA, BMS, MES, Historian, and data integrity.

What is the company culture like at Eli Lilly Foundry?

The culture emphasizes significant collaboration, creativity, and resilience as the site grows to full-scale GMP manufacturing, with a focus on putting people first, technical leadership, mentorship, and building a new organization during project startup.

What makes a strong candidate for this Senior Principal Engineer position?

Strong candidates will have technical leadership experience, expertise in CSV and process control systems, ability to mentor teams, and skills in validation planning, risk assessments, and ensuring regulatory compliance in a dynamic startup environment.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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