Principal CSV Engineer – Automation Engineering

Eli Lilly and Company

. Serve as a technical subject matter expert providing automation support for operating areas and capital projects .

Posted 11/5/2026full-timeLebanon • United StatesLead💰 $67,500 - $173,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computer System Validation (CSV), ensuring compliance with regulatory standards such as GAMP and 21 CFR Part 11, while providing technical leadership in Automation Engineering within the biopharma sector. Proficient in managing validation protocols and maintaining data integrity across various automation systems.

Highest-signal resume keywords

Computer System Validation (CSV)Automation EngineeringGMP/GXP ComplianceSCADA, DCS, MES ExperienceTechnical Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Computer System ValidationAutomation EngineeringProcess Control ValidationRisk AssessmentValidation Protocol DevelopmentData IntegrityGMP ComplianceRegulatory RequirementsProject ManagementInterconnectivity of Systems

Soft Skills

Problem-SolvingWritten CommunicationVerbal CommunicationOrganizational SkillsInfluencing Skills

Tools & Technologies

DeltaVRockwellSyncadeLabVantageOSI PIKneatALMValGenesis

Industry Keywords

Biopharma AutomationPharmaceutical ManufacturingGreenfield ManufacturingQuality ComplianceVendor Audits

About the role

Key responsibilities & impact

Serve as a technical subject matter expert providing automation support for operating areas and capital projects
Provide technical leadership for CSV activities for process automation systems across the site
Collaborate with cross-functional teams to validate systems critical to manufacturing life-changing products
Ensure reliable and compliant control applications and systems support manufacturing operations
Lead process control validation testing, implementation, and coordination
Lead development and implementation of the Automation Engineering Project Validation Plan
Serve as subject matter expert for computer system validation and data integrity across DCS, SCADA, BMS, MES, Historian, vendor packaged equipment, ASRS, and QMS
Lead risk assessments for computerized systems and develop risk mitigation strategies
Lead development and execution of validation protocols
Ensure compliance with GAMP, 21 CFR Part 11, data integrity requirements, and Lilly quality policies
Generate and maintain validation plans, summary reports, SOPs, and work instructions
Provide technical leadership for change control and deviation management related to CSV
Collaborate with vendors and conduct vendor audits as needed
Train and provide technical guidance on CSV principles and best practices
Represent Automation during regulatory agency audits
Act as functional owner for Kneat, ALM, and ValGenesis electronic testing systems
Review design documentation and participate in design and automation software reviews
Provide project management status updates
Develop CSV and quality strategies with Site Quality
Implement and support electronic systems used to capture production data
Maintain the validated state of site control systems
Provide automation support for capital projects and new product introductions
Promote automation to improve productivity, efficiency, and compliance
Develop corporate contacts and leverage corporate expertise

Requirements

What you’ll need

Minimum B.S. in Engineering or related degree
Minimum of 5 years of experience at the Principal Engineer level
Minimum of 8+ years of experience at the Senior Principal level
Working experience in Biopharma Automation Engineering, preferably in major pharmaceutical manufacturing
Experience with design, development, commissioning, or qualification of computer systems
Deep knowledge of GMP/GXP, regulatory requirements, computer system validation, and data integrity
Experience in Automation Engineering, preferably in major pharmaceutical manufacturing
Experience with highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, and Site Historian systems
Experience with DeltaV, Rockwell, Syncade, LabVantage, and OSI PI
Experience commissioning, qualifying, and supporting systems between SCADA, DCS, MES, LIMS, Historian, and other applications for interconnectivity
Experience ensuring quality compliance and data integrity
Experience facilitating and driving decision-making at an organizational level
Strong knowledge of GMP, regulatory requirements, and computer system validation
Strong planning, organizational, prioritization, problem-solving, written communication, and verbal communication skills
Ability to influence peers and business partners and provide technical leadership across cross-functional teams

Benefits

Comp & perks

Company bonus, depending in part on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Employee assistance program
Fitness benefits
Employee clubs and activities