Lab Instruments Software Validation Analyst / Technical Writer

Lab Instruments Software Validation Analyst / Technical Writer10/13/2025ContractActiveJob Description:Job SummaryWe are seeking a detail-oriented Software Validation Analyst / Technical Writer to document and validate software installed on laboratory instrumentation in accordance with EMA guidelines.This role involves migrating software management processes, writing technical documentation, and performing risk assessments to ensure compliance and reliability.Key ResponsibilitiesDocument and validate lab instrument software in alignment with EMA regulatory guidelines.Migrate software management to standardized IT SOPs.Gather and document software requirements and configurations.Write validation test cases for lab instrument software.Create detailed software specifications and supporting documentation.Develop infrastructure diagrams to represent system architecture.Create data flow diagrams to illustrate software interactions.Perform risk assessments related to software and instrumentation.Required QualificationsMinimum 3 years of experience in technical writing, preferably in scientific or laboratory environments.Minimum 3 years of experience performing risk assessments for software systems.Minimum 3 years of experience creating infrastructure and data flow diagrams.Strong communication skills for effective collaboration with cross-functional teams.Detail-oriented approach to documentation and validation tasks.Familiarity with EMA guidelines and software validation practices. #J-18808-Ljbffr