✦ Luna Orbit — Engineering (Non-Software)

Senior Engineer - Project Engineering

at Amgen

📍 US - North Carolina - Holly Springs Unknown Posted March 13, 2026
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Position Details

Type Not Specified
Experience senior
Exp. Years 5+ years
Education Not specified
Category Engineering (Non-Software)

About this role

This role involves leading project engineering efforts in biotech manufacturing, focusing on validation, qualification, and automation to support a new advanced drug substance plant.

Key Responsibilities

  • Lead validation efforts
  • Manage capital projects
  • Ensure GMP compliance
  • Develop automation/AI tools
  • Maintain inspection readiness

Technical Overview

Environment includes validation systems, automation tools, AI applications, and GMP standards, with a focus on system lifecycle management and inspection readiness.

Ideal Candidate

The ideal candidate is a senior project engineer with extensive experience in biotech or pharmaceutical manufacturing, specializing in validation, qualification, and capital project management, with a focus on GMP compliance and automation.

Must-Have Skills

Experience with project engineering in biotech/pharmaValidation and qualification expertiseExperience with capital projectsKnowledge of GMP standardsAutomation/AI tools developmentInspection readiness

Nice-to-Have Skills

Experience with computerized systemsKnowledge of industry 4.0 technologiesExperience in biotech manufacturing

Tools & Platforms

CCMSAutomation toolsAI toolsValidation systems

Required Skills

Project EngineeringValidationQualificationCapital ProjectsCCMSAutomationAI toolsInspection ReadinessGMP

Hard Skills

Project EngineeringValidationQualificationCapital ProjectsCCMSAutomationAI toolsSystem LifecycleInspection ReadinessGMPManufacturing

Soft Skills

LeadershipTechnical oversightOperational managementCollaborationProblem-solving

Industry & Role

Industry Pharmaceuticals / Biotechnology
Job Function Oversee project engineering and validation for biotech manufacturing facilities

Keywords for Your Resume

Project EngineeringValidationQualificationCapital ProjectsCCMSAutomationAI toolsSystem LifecycleInspection ReadinessGMP

Deal Breakers

Lack of biotech/pharma project experience, No validation or qualification background, Less than 5 years of relevant experience

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