Responsibilities
- Deliver advanced operational support for centralized lab and enterprise software, handling incidents from critical to low severity following ITIL guidelines.
- Carry out scheduled system updates, patches, preventive maintenance, and health assessments to maintain platform integrity.
- Monitor application, database, and virtual infrastructure performance to detect and prevent service outages.
- Maintain compliance with GxP regulations, data integrity standards, and internal quality policies.
- Participate in Computer System Validation tasks, including Installation Qualification execution.
- Participate in Computer System Validation tasks, including Operational Qualification execution.
- Participate in Computer System Validation tasks, including Performance Qualification execution.
- Conduct risk evaluations as part of Computer System Validation processes.
- Verify data integrity as required during validation and audit cycles.
- Ensure systems adhere to GAMP 5, 21 CFR Part 11, and EU Annex 11 regulatory frameworks.
- Assist in internal and client-led audits, inspections, and validation assessments.
- Manage and coordinate incident, change, problem, and exception workflows.
- Support root cause investigations and help define and track corrective and preventive actions (CAPA).
- Collaborate with infrastructure, quality assurance, validation, and vendor teams to resolve technical issues efficiently.
- Serve as technical expert for key laboratory applications, including Empower.
- Serve as technical expert for key laboratory applications, including NuGenesis.
- Serve as technical expert for key laboratory applications, including LabSolutions.
- Serve as technical expert for other regulated lab systems as needed, such as chromatography data systems, scientific data management systems, and instrument control software.
- Coordinate software version upgrades, configuration adjustments, and lifecycle planning with central teams and local sites.
- Engage with software vendors to diagnose problems and implement recommended solutions.
- Create and maintain automation scripts to enhance system reliability, monitoring, and process consistency.
- Support automated workflows—such as job scheduling and scripted maintenance—when aligned with compliance and operational needs.
- Utilize PowerShell and other scripting tools to automate repetitive administrative and monitoring tasks.
- Develop and manage scheduled jobs and automated processes that support application operations.
- Demonstrate proficiency with Oracle and SQL databases used by laboratory systems.
- Support virtual machine environments, including setup and configuration tasks.
- Maintain validated virtual machine images, with experience in creating such images considered a significant asset.
Work Arrangement
Remote — Barcelona, Spain
