Technical Writer

Overview

We are seeking a detail-oriented Technical Writer to support documentation activities within a regulated pharmaceutical or medical device manufacturing environment. This role is responsible for creating, revising, formatting, and maintaining technical and quality documentation in compliance with GMP and internal quality standards. The ideal candidate will have experience translating complex technical information into clear, accurate, and user-friendly documents while supporting cross-functional teams in a highly regulated setting.

Job Duties

• Create, revise, edit, and format controlled technical documents including SOPs, work instructions, protocols, reports, specifications, forms, and training documents
• Support documentation updates related to manufacturing processes, equipment, validation, quality systems, and engineering changes
• Ensure all documentation complies with GMP, GDP, and internal documentation standards
• Collaborate with subject matter experts across Quality, Manufacturing, Engineering, Regulatory, and Validation to gather and clarify technical content
• Manage document workflows through the document control system, including routing, review, approval, and archival
• Maintain consistency in document structure, terminology, formatting, and revision history
• Assist with change control documentation and support quality system initiatives
• Review existing documentation for accuracy, completeness, and compliance
• Support audit readiness by ensuring documentation is current, traceable, and inspection-ready
• Participate in continuous improvement efforts related to documentation processes and quality systems

Qualifications

• Bachelor’s degree in Technical Writing, English, Life Sciences, Engineering, or related field preferred
• 2+ years of technical writing experience in a regulated pharmaceutical, biotech, or medical device environment
• Strong understanding of GMP documentation requirements, document control, and quality systems
• Experience with controlled documentation such as SOPs, validation protocols, deviations, CAPAs, or batch records
• Proficiency in Microsoft Office Suite and electronic document management systems
• Strong written, verbal, organizational, and proofreading skills
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment

Preferred Qualifications

• Experience supporting validation, quality assurance, regulatory affairs, or manufacturing operations
• Familiarity with systems such as Veeva, MasterControl, TrackWise, Documentum, or similar platforms
• Experience in an FDA-regulated environment with exposure to audits and inspections
• Knowledge of medical device design control documentation or pharmaceutical manufacturing documentation is a plus

Benefits

• PTO
• Paid holidays
• BCBS medical plans
• Dental plans
• Vision plans
• 401(k)
• ESOP