About This Role
This Technical Writer role supports the development, revision, and management of manufacturing and engineering documentation within a GMP-regulated environment. The core of the job involves converting complex engineering, validation, and technical documents into clear, compliant, and user-friendly Standard Operating Procedures (SOPs) and other controlled documentation. It suits a detail-oriented candidate with experience in regulated pharmaceutical, medical device, consumer health, or life sciences environments, possessing strong document management skills.
Responsibilities
- Review and interpret engineering, technical, validation, and operational documents
- Transform technical content into clear, concise, and compliant SOPs, work instructions, and controlled documents
- Collaborate with engineers, quality, validation, manufacturing, and cross-functional teams to gather and verify technical information
- Ensure documentation aligns with GMP requirements, company standards, and document control procedures
- Manage document review cycles, incorporating stakeholder feedback and maintaining version control
- Coordinate approval workflows and actively facilitate the collection of required signatures and approvals
- Maintain documentation accuracy, consistency, formatting, and traceability
- Utilize Microsoft Word to develop and format professional documentation templates and final deliverables
- Use Adobe Acrobat to review, edit, compile, and manage controlled PDF documentation
- Support document archival, revision management, and document management system activities as required
- Identify opportunities to improve documentation processes and standardization
Requirements
- Bachelor's degree in Technical Writing, English, Communications, Engineering, Life Sciences, or a related field, or equivalent experience
- 2-4 years of technical writing experience in a GMP-regulated environment
- Experience creating and editing SOPs, work instructions, controlled documents, or quality system documentation
- Proficiency in Microsoft Word, including advanced formatting, styles, templates, tables, and document controls
- Proficiency in Adobe Acrobat for document editing, review, and PDF management
- Strong attention to detail with excellent proofreading and editing capabilities
- Ability to interpret technical and engineering information and translate it into end-user documentation
- Strong organizational, communication, and stakeholder management skills
Nice to have:
- Experience supporting pharmaceutical, consumer health, biotechnology, medical device, or manufacturing operations
- Familiarity with document management systems and controlled document workflows
