Technical Writer

The Technical Writer is responsible for supporting the overall GMP upstream and downstream manufacturing process, through the application of broad technical writing experiences, developing standard operating procedures for manufacturing processes as well as routine tasks in the production of bulk biologics therapies. • Generates/revises manufacturing batch records, both in the electronic batch recordsystem (PAS-X) and the document management system• Generates/revises standard operating procedures and other related documents in clearand easy to understand language• May assist with the management of change controls in the Quality Management System• Technical Writing Support of Upstream, Downstream and Central Services• Manage updates and revisions to technical process documentation• Interfaces across multiple departments with subject matter experts for review andapproval of documentation and changes• Self-manages time to complete work based on critical timelines Requirements:• Previous experience in Biotechnology/Pharmaceutical Manufacturing• Excellent written and verbal communication skills• Proficiency in MS Office, specifically MS Word and Visio• Strong attention to detail• Able to write in explanatory and procedural styles for multiple audiences• Skilled at prioritization and multi-tasking• Proven experience working in a technical writing position preferred• Experience with PAS-X/electronic batch records and change management preferred Education:• BA preferred• Science degree (chemistry, biology, engineering, pharmacy) or experience in LifeSciences technical writing preferred.