What are the responsibilities and job description for the Facilities Engineering Technical/Deviation Writer position at The Accuro Group?
Business Title : 105408 | Facilities Engineering Technical / Deviation WriterLocation : Cambridge, MA 02142Job Type : Contract (12 M )Note : Nearby garage parking is available for roughly $420 / month. Parking will not be reimbursed by the client.Job Description : The Tech Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the FEV (Facilities, Engineering and Validation) department, as well as revising and writing procedures, and acting as document coordinator.Job Responsibilities : Update, author and review FEV standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap AssessmentsPerform investigation activities and writing deviation investigation reports for FEV departmentsCollaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practicesCoordinate 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 analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrenceParticipate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation processInitiate Change Controls as required for Engineering / Facilities operationsManage Facilities Engineering GMP documents through lifecycle as document coordinator Skills & Experience Required : Bachelor's degree in relevant field3 years of pharmaceutical industry experience3 years of technical experience in a regulated GxP environmentDemonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing / packaging processesExperience in troubleshooting, investigation, and root-cause / analytical / problem-solving for equipment related issuesDemonstrated, 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 SAP or similar deviation management system, and Veeva or similar quality document system.
Salary : $420
