Principal CSV Engineer, Automation Validation Lead
BioSpace
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Benefits offered by this job
Job summary
Lilly, a global healthcare leader headquartered in Indianapolis, IN, seeks an experienced Automation CSV Engineer to lead validation and data integrity for advanced process systems. You will shape regulatory-compliant strategies, craft validation plans, and mentor teams to ensure quality across DCS, SCADA, MES, and historian platforms.
Responsibilities include risk assessments, validation protocol execution, and collaboration with vendors to meet regulatory standards.
Qualifications
- Minimum B.S. in Engineering or related field.
- 5+ years in Biopharma Automation Engineering is preferred at senior levels.
- Experience with design, development, commissioning, or qualification of computer systems.
Responsibilities
- Lead validation testing and documentation for automation systems.
- Provide technical leadership on CSV and data integrity across the site.
- Ensure compliance with GMP, 21 CFR Part 11, and Lilly quality policies.
- Develop and execute validation plans and SOPs.
- Collaborate with vendors and lead audits as needed.
- Provide training on CSV principles and best practices.
Skills
Education
Tools
Job description
Lilly, a global healthcare leader headquartered in Indianapolis, IN, seeks an experienced Automation CSV Engineer to lead validation and data integrity for advanced process systems. You will shape regulatory-compliant strategies, craft validation plans, and mentor teams to ensure quality across DCS, SCADA, MES, and historian platforms.
Responsibilities include risk assessments, validation protocol execution, and collaboration with vendors to meet regulatory standards.
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