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Manufacturing Engineer II

Headhunter: Planet Pharma

Headhunter: Planet Pharma

Pharmaceutical Research Industry

Boulder, CO - USA

Senior Specialist / Project Manager

Experteer Overview

As a PMO Operations Engineer, you drive MDR and capital projects across product lines to optimize cost, quality, and delivery. You’ll partner with R&D, Quality, Operations, and Supply Chain to implement scalable manufacturing solutions that comply with regulatory policies. Your work centers on project governance, financial management, and process validation to keep the business running efficiently. This role offers impact through cross-functional leadership and continuous improvement in a life-saving device environment.

Responsibilities

  • Manage MDR project schedules and lead cross-functional engineering and capital initiatives
  • Oversee project finances including spend forecasts, PO drafting, capitalization, and budget tracking
  • Lead cost savings, capacity expansion, and run-the-business projects from proposal through implementation
  • Execute IQ/OQ/PQ validations using statistical tools
  • Provide process engineering support for production problems and equipment/process troubleshooting
  • Create and maintain technical specifications and SOPs via document control system
  • Drive continuous improvement focusing on yield, efficiency, quality, and cost
  • Collaborate with suppliers and contract manufacturers for equipment implementation and technical alignment

Key requirements

  • Project Management
  • Manufacturing engineering experience in regulated environment (Medical Device preferred)
  • Financial / Business Acumen
  • Bachelor in Engineering
  • 2 years or advanced degree

Description

As a PMO Operations Engineer, you drive MDR and capital projects across product lines to optimize cost, quality, and delivery. You’ll partne…
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