Sr. Technical Writer- LabVantage
The Sr. Technical Writer supports a global LabVantage LIMS implementation by authoring, revising, and managing GMP documentation including SOPs, forms, job aids, and validation evidence. This role leverages approved AI tools, including Claude and Copilot, to accelerate document generation, review, and testing while maintaining compliance and inspection readiness.
Key Responsibilities:
Author and revise GMP documentation (SOPs, forms, job aids, validation evidence) supporting LabVantage deployment
Leverage AI tools (Claude, Copilot) to accelerate document drafting, review cycles, and test coverage
Update legacy documentation to reflect standardized LabVantage workflows and remove obsolete scripting
Coordinate with QA, QC, IT, and document control teams to ensure inspection-ready content
Manage document versioning, routing, and approval workflows
Support rapid documentation testing and validation using AI-assisted approaches
Create approved GMP documents, forms, and job aids
Document control records and version history
Generate AI-accelerated draft documentation and testing outputs
Required Qualifications:
5+ years of technical writing experience in GMP-regulated pharma or biotech environments
Hands-on experience authoring SOPs, validation documentation, and regulated technical content
Experience using AI tools (Claude, Copilot, or similar) to improve documentation efficiency
Strong knowledge of document control, compliance, and inspection readiness
Preferred Qualifications:
Experience supporting LIMS implementations (LabVantage preferred)
Exposure to global, multi-site pharmaceutical programs
Familiarity with AI-driven document testing and validation techniques

Technical Writer- LabVantage
Apex Systems · New York, NY, USA ·
- Job type:
- Full Time