Position Description:
We are seeking a detail-oriented and highly organized Technical Writer to support documentation, governance, and transition initiatives during the separation and migration of systems and processes from one biotechnology organization to another.
This role will focus on SOP development (new and change), process documentation, document control governance, and providing Project Management and Computer System Validation (CSV) support. The ideal candidate is fluent in English, experienced in regulated environments, and capable of managing complex documentation initiatives within biotechnology or life sciences industries.
Responsibilities:
- Author, revise, and maintain SOPs (new and change) in compliance with GxP and quality standards.
- Develop and standardize process documentation, workflows, and system transition materials.
- Establish and maintain document control governance, including version control and archival practices.
- Support change management activities related to documentation updates and system transitions.
- Provide documentation support for Computer System Validation (CSV), including validation lifecycle documents (e.g., URS, IQ/OQ/PQ).
- Coordinate cross-functionally with Quality, IT, Regulatory, and Operations to ensure documentation accuracy and compliance.
- Track documentation deliverables, timelines, and milestones in support of project management activities.
- Support audit and inspection readiness by ensuring documentation integrity and traceability
Qualifications:
- Strong English communication skills (written and verbal).
- 3+ years of experience in technical writing within biotechnology, pharmaceutical, or regulated industries.
- Experience developing SOPs in a GxP environment.
- Knowledge of document control and governance best practices.
- Experience supporting CSV documentation.
- Proficiency with document management systems (e.g., Veeva, MasterControl, SharePoint).
