Technical Writer

Role Overview

We have an opening in the Manufacturing Support team for a Technical Writer. This position entails full ownership and management of critical change controls related to site development, alongside handling updates to operational documentation as projects evolve.

Primary Responsibilities

• Create, revise, and maintain operational procedures aligned with both site and corporate standards, acting as the responsible document owner.
• Support the creation of training resources and occasionally assist in delivering training sessions covering scientific or technical facets of the process.
• Collaborate closely with Manufacturing, Inspection, and Engineering teams to ensure timely and effective documentation updates.
• Develop manufacturing and inspection protocols to facilitate change controls, address non-conformances, and assist troubleshooting efforts, working in partnership with subject matter experts.
• Participate in projects centered on enhancing processes continuously and troubleshooting activities.
• Take ownership of change control documentation and manage these activities.
• Prepare and update paper batch records in accordance with the production calendar.
• Work alongside Quality Assurance to guarantee compliance with Good Manufacturing Practice (GMP) standards and current operational specifications.
• Coordinate with Operations leaders and relevant SMEs to confirm documentation updates are accurate and align with project timelines and deliverables.
• Conduct data analysis on documentation trends post-project completion to identify systemic issues or processing errors.
• Assist in verifying data in protocols, reports, and risk assessments governed by Operations.
• Support the production team by contributing towards minimizing document processing turnaround.
• Utilize prescribed software tools and follow standard operating procedures to compile and manage relevant documents, including SOPs.
• Provide technical and administrative assistance to manufacturing, inspection, and engineering departments in report preparation, data collation, and SOP tracking.
• Monitor and triage non-conformance reports to meet established timelines; serve as a deviation owner for minor issues.
• Manage corrective and preventive actions, including verifying their effectiveness.
• Help execute commissioning and qualification (C&Q), characterization, and functional testing protocols as required by projects.
• May require flexibility in working hours to meet project and operational needs.

Experience and Qualifications

• Possess strong project management and organizational skills, demonstrating the ability to see assignments through to completion.
• Hold a Bachelor’s degree in a Science or Engineering field.
• Have at least 3 years’ professional experience in Chemistry, Microbiology, Engineering, or Validation within biotech, pharmaceutical, or healthcare sectors.
• Familiarity with regulatory compliance for current Good Manufacturing Practice (cGMP) in the manufacture and testing of pharmaceutical products is advantageous.
• Exceptional communication skills, both written and oral, with demonstrated proficiency in technical writing for GMP-related documentation like investigations, procedures, and change controls, in addition to effective presentation capabilities.
• Escalate problems promptly and maintain professionalism in communications.
• Maintain compliance rigorously within a regulated environment.
• Demonstrate independence and deliver high-quality results with minimal supervision.
• Experience leading or contributing to cross-functional teams.
• Capable of managing multiple priorities simultaneously in a dynamic, fast-paced workplace.