✦ Luna Orbit — Engineering (Non-Software)

Engineer II, Facilities

at Biogen

📍 Research Triangle Park, NC Unknown 💰 $65K – $85K USD / year Posted March 13, 2026
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Position Details

Salary $65K – $85K USD / year
Type Full-Time
Experience mid
Exp. Years 0-1 years
Education Bachelor's degree in Engineering
Category Engineering (Non-Software)

About this role

This role supports validation activities for GMP equipment, focusing on temperature-controlled chambers, ensuring compliance and supporting continuous improvement in a biotech manufacturing setting.

Key Responsibilities

  • Support validation activities
  • Assist with IQ/OQ/PQ protocols
  • Participate in equipment qualification
  • Troubleshoot equipment issues
  • Support change controls and deviations

Technical Overview

The environment involves GMP validation, equipment qualification, and regulatory compliance, with exposure to IQ/OQ/PQ protocols and validation tools.

Ideal Candidate

The ideal candidate is a motivated engineer with a background in GMP validation, experienced in equipment qualification and GMP compliance, eager to support validation activities in a manufacturing environment.

Must-Have Skills

Bachelor's degree in EngineeringUnderstanding of FDA cGMP regulationsProficiency with Microsoft WordExcelPowerPointWillingness to support extended hours

Nice-to-Have Skills

Experience supporting deviationsinvestigationschange controlsExposure to temperature-controlled chambersFamiliarity with IQ/OQ/PQ documentationExperience in biotech/pharma manufacturingInterest in equipment validation

Tools & Platforms

Microsoft WordMicrosoft ExcelMicrosoft PowerPointValidation tools such as Kaye or LIVES data loggers

Required Skills

GMPValidationIQOQPQEquipment QualificationTemperature-controlled ChambersDeviationsCAPAsDocumentation

Hard Skills

GMPGood Manufacturing PracticeValidationIQOQPQEquipment QualificationTemperature-controlled ChambersUtilitiesTroubleshootingChange ControlsDeviationsCAPAsDocumentationRegulatory ComplianceFDA cGMP

Soft Skills

MotivatedLearningTeamworkCommunicationProblem-solvingDetail-oriented

Industry & Role

Industry Manufacturing
Job Function Validation and qualification of GMP equipment in biotech manufacturing

Keywords for Your Resume

GMPGood Manufacturing PracticeValidationIQOQPQEquipment QualificationTemperature-controlled ChambersUtilitiesTroubleshootingChange ControlsDeviationsCAPAsDocumentationRegulatory ComplianceFDA cGMP

Deal Breakers

Lack of engineering degree, No experience with GMP validation or equipment qualification, Unwillingness to support extended hours

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