Facilities Engineering Technical/Deviation Writer at The Accuro Group

Business Title: 104241 | Facilities Engineering Technical/Deviation Writer
Location: Cambridge, MA 02142
Job Type: Contract (6 M+)
Note: Hybrid Position.

Job Description:

• The Tech Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Engineering, Facilities and Validation departments, As well as revising and writing procedures, and acting as document coordinator.

 
Job 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 as well as identify opportunities for continuous process improvements
• 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 and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent a recurrence
• 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, Gap Assessments
• 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

 
Skills & Experience Required:

• 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