Hi,
Hope you are doing well.
Job Title: Sr IT Technical Writer
Location: Remote
Duration:12+ Months
Job Description
We are seeking a Senior IT Technical Writer with 10+ years of experience to support technical documentation initiatives within a Bio-Pharma/Life Sciences environment.
The consultant will work closely with IT, engineering, application, infrastructure, quality, validation, and business teams to develop accurate and compliant documentation for regulated systems.
The role involves creating and maintaining SOPs, work instructions, system documentation, validation documents, user guides, technical procedures, configuration documents, training materials, and knowledge-base content.
The ideal candidate should have experience working in GxP-regulated environments and understand documentation requirements related to FDA regulations, 21 CFR Part 11, GxP, CSV/CSA, change control, validation, and audit readiness.
Key Responsibilities
- Develop and maintain SOPs, work instructions, technical procedures, system manuals, and user guides.
- Document IT applications, infrastructure, laboratory systems, manufacturing systems, and integrations. Collaborate with SMEs, IT, Quality, Validation, Engineering, and Business teams.
- Support documentation for computer system validation (CSV), system implementations, upgrades, and changes.
- Ensure documentation follows GxP, FDA, 21 CFR Part 11, and company quality standards. Review and update documentation for audits, inspections, releases, and system changes.
- Create process flows, diagrams, screenshots, and technical reference materials. Maintain controlled documentation using tools such as SharePoint, Confluence, Veeva, Documentum, Jira, or similar platforms.