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Facilities Engineering Technical Writer
2 months ago
Job Title: Facilities Engineering Technical Writer
Company: The Accuro Group
Location: Remote
Job Type: Contract (6 months+)
Job Description:
The Technical Writer will be responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Engineering, Facilities, and Validation departments. As a key member of the team, you will be responsible for revising and writing procedures, and acting as document coordinator.
Key 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
- 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
- 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
- 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
Requirements:
- 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
- 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
What We Offer:
- Opportunity to work in a dynamic and growing company
- Collaborative and supportive work environment
- Professional development and growth opportunities
- Competitive compensation and benefits package