✦ Luna Orbit — Engineering (Non-Software)

Associate Director, Process Engineering - Oral Solid Dosage, Clinical Manufacturing (Onsite)

at Merck

📍 USA - New Jersey - Rahway Hybrid 💰 $142K – $224K USD / year Posted March 14, 2026
Salary $142K – $224K USD / year
Type Full-Time
Experience mid
Exp. Years 5+ years
Education Not specified
Category Engineering (Non-Software)

This role involves leading process engineering efforts in a GMP manufacturing setting, focusing on process robustness, scale-up, and continuous improvement for drug product manufacturing.

  • Lead process development
  • Ensure GMP compliance
  • Perform process robustness assessments
  • Manage deviations and change controls
  • Support scale-up activities

Expertise in GMP processes, process development, Design of Experiments, Quality by Design, and process validation. Experience with small-molecule manufacturing is preferred.

The ideal candidate is a process engineer with 5+ years of experience in GMP manufacturing and process development, skilled in process robustness, root cause analysis, and scale-up activities for drug products.

experience in GMP manufacturingauthoring GMP documentationprocess robustness assessmentsroot cause analysischange control
experience with biologics or vaccinesscale-up to commercial manufacturingDesign of ExperimentsQuality by Design
GMP documentation toolsprocess development software
Process EngineeringGMPbatch manufacturingscale-upDesign of ExperimentsQuality by Designprocess robustnessroot cause analysischange controldeviation management
Process EngineeringGMPbatch manufacturingscale-upDesign of ExperimentsQuality by Designprocess robustnessroot cause analysischange controldeviation managementsmall-molecule processingdrug product manufacturing
leadershiptechnical coachingcollaborative communicationproblem-solvingproject managementinnovationteam building
Industry Pharmaceuticals
Job Function Lead process engineering for pharmaceutical manufacturing
Process EngineeringGMPbatch manufacturingscale-upDesign of ExperimentsQuality by Designprocess robustnessroot cause analysischange controldeviation managementsmall-moleculedrug product

Lack of GMP manufacturing experience, No experience with process validation or scale-up, No familiarity with GMP documentation, Unwilling to work in a hybrid environment

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