Principal CSV Engineer, Automation for GMP Biopharma

Eli Lilly and Company

Lebanon (IN)

Sur place

USD 68 000 - 174 000

Plein temps

Il y a 8 jours

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Avantages offerts par ce poste

Company 401(k)
Pension plan
Vacation benefits
Medical, dental, vision
Flexible benefits
Life insurance
Time off and leaves
Well-being programs

Résumé du poste

Eli Lilly and Company is seeking an Automation Engineer focused on Computer System Validation (CSV) to support process control systems at the Lilly Medicines Foundry in Lebanon, IN. You will provide technical leadership across DCS, SCADA, BMS, MES, and related systems, ensuring compliant, validated operations for GMP manufacturing.

The role emphasizes cross‑functional collaboration, project leadership, and ongoing improvement in validation strategies and data integrity.

Qualifications

  • B.S. in Engineering or related field required.
  • 5+ years in Biopharma Automation Engineering preferred.
  • Experience with design, development, commissioning, or qualification of computer systems.

Responsabilités

  • Lead process control validation testing, implementation, and coordination.
  • Lead development and implementation of Automation Engineering Project Validation Plan.
  • Serve as SME for computer system validation and data integrity for automation systems across the site.
  • Lead risk assessments for computerized systems and mitigation strategies.
  • Lead validation protocol development and execution for computerized systems.
  • Ensure compliance with GMP, 21 CFR Part 11, and data integrity standards.

Connaissances

Process control validation
CSV
GMP knowledge
Regulatory compliance
Data integrity

Formation

B.S. in Engineering

Outils

DCS
SCADA
BMS
MES
Historian
Kneat
ALM
ValGenesis

Description du poste

Eli Lilly and Company is seeking an Automation Engineer focused on Computer System Validation (CSV) to support process control systems at the Lilly Medicines Foundry in Lebanon, IN. You will provide technical leadership across DCS, SCADA, BMS, MES, and related systems, ensuring compliant, validated operations for GMP manufacturing.

The role emphasizes cross‑functional collaboration, project leadership, and ongoing improvement in validation strategies and data integrity.

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