Facilities Engineering Technical Writer

4 weeks ago


Cambridge, Massachusetts, United States Alphanumeric Systems Inc. Full time
Job Title: Facilities Engineering Technical Writer

Alphanumeric Systems Inc. is seeking a skilled Facilities Engineering Technical Writer to join our team in Cambridge, MA. As a key member of our Facilities, Engineering, and Validation (FEV) department, you will be responsible for performing GxP investigation activities and owning and authoring deviation investigation reports. Your expertise in technical writing and regulatory compliance will ensure that our procedures and documents meet the highest standards.

Key Responsibilities:
  • Update, author, and review FEV standard operating procedures and other controlled documents.
  • Perform investigation activities and write deviation investigation reports for FEV departments.
  • Collaborate with Subject Matter Experts (SMEs) from other departments to ensure cross-functional evaluation and alignment of GxP practices.
  • Coordinate prompt event evaluation, investigation, closure, and follow-up of process/equipment discrepancies and related areas.
  • Write concise and accurate investigation reports.
  • Utilize root cause analysis, analytical, and problem-solving tools to determine root cause of GxP deviations and assist with impact analysis and identification of corrective actions.
  • Participate in determining appropriate corrective and preventative actions (CAPAs) after the investigation process.
  • Initiate Change Controls as required for Engineering/Facilities operations.
  • Manage Facilities Engineering GMP documents through lifecycle as document coordinator.
Requirements:
  • Bachelor's degree in a scientific/engineering discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.
  • Demonstrate a sound understanding of cGMPs, FDA regulations, and pharmaceutical manufacturing/packaging processes.
  • Minimum of 3 years technical experience in a regulated GxP environment.
  • Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving for equipment-related issues.
  • Demonstrated strong technical writing skills with the ability to read, comprehend, and communicate complex technical events.
  • Demonstrated ability to work independently and as part of a collaborative, cross-functional team.
  • Working knowledge of SAP or similar deviation management system, and Veeva or similar quality document system.

About Alphanumeric Systems Inc.: Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. We treat our candidates as amazing (because they are) Apply today to join our family and Make Your Mark


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