The Accuro Group
Facilities Engineering Technical/Deviation Writer
The Accuro Group, Cambridge, Massachusetts, us, 02142
Business Title: 104241 | Facilities Engineering Technical/Deviation Writer
Find out more about this role by reading the information below, then apply to be considered.Location: Cambridge, MA 02142Job 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 departmentsCoordinate prompt event evaluation, investigation, closure, and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvementsWrite concise and accurate investigation reportsUtilize 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 recurrenceParticipate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation processUpdate, author, and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap AssessmentsInitiate Change Controls as required for Engineering/Facilities operationsCollaborate with SMEs from other departments to ensure a cross-functional evaluation is completed and ensure alignment of GxP practicesManage Facilities Engineering GMP documents through lifecycle as document coordinator
Skills & Experience Required:
Bachelor's degree in a relevant field3-5 years of experience in a pharmaceutical or related industryMinimum of 3 years of technical experience in a regulated GxP environmentExperience 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 processesDemonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear, and accurateWorking knowledge of TrackWise, SAP or similar deviation management system, and Veeva or similar quality document system
Find out more about this role by reading the information below, then apply to be considered.Location: Cambridge, MA 02142Job 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 departmentsCoordinate prompt event evaluation, investigation, closure, and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvementsWrite concise and accurate investigation reportsUtilize 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 recurrenceParticipate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation processUpdate, author, and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap AssessmentsInitiate Change Controls as required for Engineering/Facilities operationsCollaborate with SMEs from other departments to ensure a cross-functional evaluation is completed and ensure alignment of GxP practicesManage Facilities Engineering GMP documents through lifecycle as document coordinator
Skills & Experience Required:
Bachelor's degree in a relevant field3-5 years of experience in a pharmaceutical or related industryMinimum of 3 years of technical experience in a regulated GxP environmentExperience 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 processesDemonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear, and accurateWorking knowledge of TrackWise, SAP or similar deviation management system, and Veeva or similar quality document system