APR Consulting
Technical Writer
APR Consulting, Cambridge, Massachusetts, United States,
A healthcare client is looking for a Facilities Engineering Technical/Deviation Writer
Location: Cambridge, MA 02142Position: Facilities Engineering Technical/Deviation WriterPay Rate: $59/hrDuration: 6 monthsExpected Shift: Monday – Friday 8-5pmHYBRID: 4 days on site/1 day at home per week
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.
Primary Responsibilities:Update, author and review FEV standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap Assessments.Perform investigation activities and writing deviation investigation reports for FEV departments.Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.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 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 recurrence.Participate in determining the 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
Education and Experience:Requires a bachelor’s degree, preferably 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 cGMP's, 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 in a manner that is concise, clear, and accurate.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 Our Client
Our client is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so they can positively impact the health of billions of peopleand deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and they aim to impact the health of 2.5 billion people around the world in the next 10 years.
Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.Don't miss out on this amazing opportunity! If you feel your experience is a match for this position please apply today and join our team. We look forward to working with you!
Location: Cambridge, MA 02142Position: Facilities Engineering Technical/Deviation WriterPay Rate: $59/hrDuration: 6 monthsExpected Shift: Monday – Friday 8-5pmHYBRID: 4 days on site/1 day at home per week
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.
Primary Responsibilities:Update, author and review FEV standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap Assessments.Perform investigation activities and writing deviation investigation reports for FEV departments.Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.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 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 recurrence.Participate in determining the 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
Education and Experience:Requires a bachelor’s degree, preferably 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 cGMP's, 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 in a manner that is concise, clear, and accurate.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 Our Client
Our client is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so they can positively impact the health of billions of peopleand deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and they aim to impact the health of 2.5 billion people around the world in the next 10 years.
Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.Don't miss out on this amazing opportunity! If you feel your experience is a match for this position please apply today and join our team. We look forward to working with you!