Position Details

Type Not Specified

Experience entry

Exp. Years Not specified

Education Not specified

Category Engineering (Non-Software)

About this role

This role supports Technology Transfer and commercial manufacturing process execution for biologics drug substance processes across Amgen’s network and/or Contract Manufacturing Organizations. You’ll apply engineering principles in cGMP to monitor performance, troubleshoot issues, and partner cross-functionally to recommend and implement process improvements.

Key Responsibilities

Provide Technology Transfer support for biologics drug substance processes in cGMP
Monitor manufacturing processes using performance indicators and troubleshoot issues
Apply statistical analysis and design of experiments (DOE) for process improvements
Collaborate cross-functionally with research, manufacturing, quality assurance and validation
Support design/engineering/construction projects within schedule and budget constraints

Technical Overview

The technical scope centers on biologics drug substance technology transfer in a cGMP environment, including routine technical tasks, manufacturing process monitoring, troubleshooting, and data-driven process improvement using statistical analysis and design of experiments (DOE). The role also coordinates with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation.

Ideal Candidate

The ideal candidate is an engineer with hands-on experience supporting Technology Transfer for biologics drug substance processes in a cGMP environment. They can monitor manufacturing performance indicators, troubleshoot processing issues, and apply statistical analysis and design of experiments (DOE) to drive process improvements.

Must-Have Skills

Technology TransfercGMP environmentStatistical analysisDesign of experimentsManufacturing process monitoringTroubleshooting

Required Skills

Technology TransfercGMP environmentdrug substance processesmanufacturing process monitoringprocess troubleshootingstatistical analysisdesign of experimentsprocess improvementsquality assurancevalidationperformance indicatorsengineering projectsfacilitiesutilities

Hard Skills

Technology TransfercGMP environmentDrug substance processesManufacturing process monitoringProcess troubleshootingStatistical analysisDesign of experimentsDesign of experiments (DOE)Process improvementsPerformance indicatorsManufacturing process troubleshootingDesignengineeringand construction projectsDesign documentsStandard design documentsFacilitiesUtilitiesQuality assuranceValidationPiping and instrumentation diagramsTroubleshooting mentorshipEquipment design

Soft Skills

CollaborativeCommunicationCollaborationMentorshipProblem-solvingCross-functional teamwork

Industry & Role

Industry Manufacturing

Job Function Lead engineering support for Technology Transfer and commercial process execution of biologics drug substance manufacturing in cGMP

Role Subtype Process Engineer

Keywords for Your Resume

EngineerTechnology TransfercGMP environmentdrug substancedrug substance processesbiologics drug substance processesmanufacturing processmanufacturing processesprocess troubleshootingtroubleshooting mentorshipstatistical analysisdesign of experimentsDOEprocess improvementsdesignengineeringand construction projectsGMPquality assurancevalidationutilitiesfacilitiesperformance indicatorsmanufacturing process monitoring

Deal Breakers

Must have experience with Technology Transfer in a cGMP environment, Must demonstrate statistical analysis and design of experiments (DOE) experience

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