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Project Engineer

3 months ago

Rensselaer, United States Insight Global Full time

Must Haves

  • 5+ years of experience with commissioning activities on bulk manufacturing sites (SLC document review, FAT testing, SAT testing, IQ/OQ Validation support, etc.)
  • Willing and able to travel frequently to Germany as needed (fully expensed)
  • Experience in detailed documentation and documentation review
  • Experience working on or within high speed fabrication lines/fill lines
  • Experience/familiarity working within regulated environments


Plusses

  • Experience working with auto injectors within high speed fabrication/fill lines
  • Ability to strategize solutions to technical issues with high speed fill line machinery
  • Experience working with GMPs, SOPs and GxP
  • Bilingual in English and German
  • Familiarity with EDMS


Day to Day

Insight Global is seeking a Project Engineer to join one of our largest Pharmaceutical clients working between their Rensselaer, NY location 5x/week onsite, and travel to their testing site in Germany. This individual will be joining a faction of the Engineering Team which will specifically be dealing with an internationally outsourced project preparing new equipment for a Factory Acceptance Test (FAT). This individual will be acting as the first line of defense and representative for Regeneron in Germany when issues within the testing site arise. This person will travel periodically to the test site in Germany to observe the team operating high-speed auto injector fill lines and will document where issues arise when utilizing the machinery. They will be expected to create detailed documentation of anything causing the reject rate of the machines to increase, compare their notes to how the machine should operate within the Synchronous Link Control (SCL) and report the issue back to the team in Rensselaer. The team is looking for someone with an eye for detail, willingness to travel, experience with commissioning in bulk manufacturing sites, and the ability to delegate tasks to team members. When not in Germany, this person will be expected to help the team with heavy documentation review to help push changes through the workflow within their EDMS system.