SARACA is a global engineering R&D services company supporting Fortune 500 customers across various industries. They are seeking an Instrument Software Validation Engineer to document and validate software for lab instruments, ensuring compliance with EMA regulatory standards and collaborating with cross-functional teams.

Responsibilities:

Document and validate software installed on lab instruments per EMA regulatory standards
Validate Instruments and Instrument Integration
Migrate instrument software management to align with PPD IT SOPs
Capture and document software requirements and configurations
Develop validation test cases and protocols related to Instruments/Medical devices, integrations and downstream workflow validation
Create infrastructure and data flow diagrams
Conduct comprehensive risk assessments
Collaborate with cross-functional teams including IT, QA, and lab operations

Requirements:

Proven experience in Instrument/Medical device validation along with integrations and downstream workflows within a regulated (GxP) environment
Strong technical writing skills for documentation and test case development
Excellent communication skills to interact with cross-functional teams
Highly detail-oriented with a focus on compliance and accuracy
Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings
Experience with risk assessment methodologies and validation lifecycle documentation
Mid to Senior Level professionals with 6–10+ years of relevant experience
Prior experience in lab instrumentation software validation is highly desirable

Instrument Software validation Engineer

Key skills

About this role

Responsibilities:

Requirements: