Specialist, CDS & SDMS, Validation
Core
Create, edit, and maintain regulated documentation (SOPs, work instructions, validation records) for the Waters Empower CDS and NuGenesis SDMS platforms to ensure alignment with GxP and data integrity requirements.
Role type
Junior Technical Writer (Validation)
Builds
Regulated documentation and validation records for the Waters Empower CDS and NuGenesis SDMS platforms
Domain
Healthcare biopharma / Computer System Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SOP creation and maintenance, IQ/OQ/PQ execution, GxP compliance, Computer System Validation (CSV), Waters Empower CDS, NuGenesis SDMS, System Development Lifecycle (SDLC), Computer System Assurance (CSA), document version control
Preferred skills
Pharma industry experience, cGMP knowledge, Laboratory processes, testing tools (JIRA, Microsoft Teams), English fluency
Technologies
Waters Empower CDS, NuGenesis SDMS, JIRA, Microsoft Teams
Responsibilities
Draft, edit, and format clear, accurate documents following templates and internal standards; Gather information from Subject Matter Experts (SMEs) and incorporate feedback; Collaborate with technical teams to build foundational knowledge of Empower systems and regulated environments
Seniority
Junior, hands-on IC
