✦ Luna Orbit — Engineering (Non-Software)

Principal Engineer TSMS Validation

at Eli Lilly

📍 US, Concord NC Unknown 💰 $66K – $171K USD / year Posted March 13, 2026
Salary $66K – $171K USD / year
Type Full-Time
Experience senior
Exp. Years 5+ years
Education Bachelor's degree (e.g., Chemical, Electrical, Computer Science), Computer Science, or a related scientific discipline
Category Engineering (Non-Software)

This role involves leading validation activities for healthcare manufacturing systems, ensuring compliance with regulatory standards, and maintaining data integrity.

  • Lead validation strategies
  • Develop validation plans
  • Ensure regulatory compliance
  • Manage validation documentation
  • Participate in audits

Focuses on validation strategies, data integrity, GxP regulations, and validation documentation within a healthcare manufacturing environment.

The ideal candidate is a senior validation engineer with at least 5 years of experience in healthcare manufacturing, specializing in computerized systems validation, data integrity, and regulatory compliance. They should have strong leadership skills and a thorough understanding of GxP regulations.

Validation strategiesGxP regulationsData integrity principlesValidation documentationRegulatory compliance
Automation validationManufacturing process controlsRisk managementAudit participation
Regulatory agenciesValidation management systems
ValidationData integrityGxP regulationsValidation strategiesValidation plansValidation protocolsValidation reportsComputerized systems validationAutomation validationManufacturing process controlsRisk managementRegulatory complianceAuditValidation documentation
Validation strategiesValidation plansValidation protocolsValidation reportsData integrity principlesGxP regulationsComputerized systems validationAutomation validationManufacturing process controlsRisk-based validationSystem lifecycle managementRegulatory complianceAudit preparationValidation documentation
LeadershipProject managementRegulatory knowledgeAttention to detailCommunicationCollaborationProblem-solvingTraining and mentorship
Industry Healthcare & Medical
Job Function Validation leadership and compliance in healthcare manufacturing
ValidationData integrityGxP regulationsValidation strategiesValidation plansValidation protocolsValidation reportsComputerized systems validationAutomation validationManufacturing process controlsRisk-based validationSystem lifecycle managementRegulatory complianceAuditValidation documentationData integrity principles

Lack of experience in healthcare validation, No familiarity with GxP regulations, Less than 5 years of validation experience, Inability to work independently in validation projects

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