Facilities Engineering Technical Writer

3 weeks ago

Cambridge, Massachusetts, United States The Accuro Group Full time
Job Title: Facilities Engineering Technical/Deviation Writer

Job Summary:

The Accuro Group is seeking a skilled Facilities Engineering Technical/Deviation Writer to join our team. As a key member of our engineering team, you will be responsible for performing GxP investigation activities, owning and authoring deviation investigation reports, and revising and writing procedures.

Key Responsibilities:

  • Perform investigation activities and write deviation investigation reports for the Engineering, Facilities, and Validation departments
  • Coordinate prompt event evaluation, investigation, closure, and follow-up of process/equipment discrepancies and related areas
  • Write concise and accurate investigation reports
  • Utilize various root cause analyses, and analytical and problem-solving tools to determine the root cause of GxP deviations
  • Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process
  • Update, author, and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs
  • Initiate Change Controls as required for Engineering/Facilities operations
  • Collaborate with SMEs from other departments to ensure a cross-functional evaluation is completed and ensure alignment of GxP practices
  • Manage Facilities Engineering GMP documents through lifecycle as document coordinator

Requirements:

  • Bachelor's degree in a relevant field
  • 3-5 years of experience in a pharmaceutical or related industry
  • Minimum of 3 years of technical experience in a regulated GxP environment
  • Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment
  • Demonstrate a sound understanding of cGMPs, FDA regulations, and pharmaceutical manufacturing/packaging processes
  • Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear, and accurate
  • Working knowledge of TrackWise, SAP or similar deviation management system, and Veeva or similar quality document system

What We Offer:

The Accuro Group offers a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.

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