Technical Lead

Job Summary

Technical Writer, SDLC Documentation (GxP Systems)   • 4-7 years of technical writing experience, with minimum 3 years specifically in GxP/regulated life sciences environments.
• Demonstrated experience authoring the full SDLC document set: URS, FRS, Design Specs, Test documentation, Release Notes, SOPs.
• Strong understanding of Computer System Validation (CSV) documentation requirements and how documentation maps to validation deliverables.
• Experience working within a formal document management/eQMS system with version control and electronic approval workflows.
• Ability to translate technical/system-level detail (from engineers, not always well-documented) into clear, standardized, audit-ready prose.
• Experience working in Agile/Scrum delivery, producing documentation aligned to sprint/release cadences rather than only end-of-project.
• Excellent written English — this is the core competency for the role.

Key Responsibilities

Technical Writer, SDLC Documentation (GxP Systems)   • 4-7 years of technical writing experience, with minimum 3 years specifically in GxP/regulated life sciences environments.
• Demonstrated experience authoring the full SDLC document set: URS, FRS, Design Specs, Test documentation, Release Notes, SOPs.
• Strong understanding of Computer System Validation (CSV) documentation requirements and how documentation maps to validation deliverables.
• Experience working within a formal document management/eQMS system with version control and electronic approval workflows.
• Ability to translate technical/system-level detail (from engineers, not always well-documented) into clear, standardized, audit-ready prose.
• Experience working in Agile/Scrum delivery, producing documentation aligned to sprint/release cadences rather than only end-of-project.
• Excellent written English — this is the core competency for the role.

Skill Requirements

Other Requirements