Process Engineer

2 weeks ago


Arvada, Colorado, United States Genovice Full time
Job Description

This is a remote position with a focus on sterile drug product technical transfers.

Key Responsibilities
  • Design process development studies based on direction from Drug Product Tech Transfer Lead
  • Author and review study protocols
  • Support planning & execution of full-scale process development, engineering, or qualification batches
  • Lead data collection, analysis, and report writing
  • Second-person review of technical documents
  • Change control support for technical transfers
  • Change control support and/or data analysis support for commercial drug product production based on business needs
Requirements
  • Solid technical writing skills (protocols, reports)
  • Able to execute a study protocol following cGMPs
  • Able to perform data analysis (statistical analysis using JMP)
  • Able to work independently and deliver results, under oversight of Tech Transfer Lead
  • Able to adapt to changes in work priorities (e.g. shift between projects)
Desired Skills/Experience
  • Experience in sterile drug product technical transfers
  • Experience with commercial manufacturing of sterile drug product
  • Experience with sterile manufacturing processes (environmental controls, aseptic techniques)
  • Change Control authoring, management, support

Location: Remote with 25% Travel. All travel expenses are paid

Pay Range: $110/Hr

Job Type: Contract 12-18 Months



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