Responsibilities
- Provide Level 2 / Level 3 operational support for centrally managed laboratory and enterprise applications, managing incidents across P1 to P4 severity levels in line with ITIL best practices.
- Perform regular maintenance, upgrades, patching, preventive maintenance, and system health checks.
- Proactively monitor applications, databases, and virtualized environments to prevent service disruption.
- Ensure systems operate in compliance with GxP, data integrity, and internal quality requirements.
- Contribute to Computer System Validation (CSV) activities, including: IQ, OQ, PQ execution.
- Contribute to risk assessments and data integrity verification.
- Ensure alignment with GAMP 5, 21 CFR Part 11, and EU Annex 11 principles.
- Support internal and customer audits, inspections, and validation reviews.
- Manage and coordinate incident, change, problem, and exception management activities.
- Support root cause analysis and contribute to CAPA definition and follow-up.
- Collaborate with Infrastructure, QA, CSV teams, and vendors to resolve issues efficiently.
- Act as a technical subject matter expert for core laboratory applications, like Empower, NuGenesis, LabSolutions.
- Support other regulated laboratory systems as required (e.g. CDS, SDMS, instrument control software).
- Coordinate software upgrades, configuration changes, and lifecycle decisions in collaboration with central teams and sites.
- Interface with application vendors to troubleshoot issues and apply best practices.
- Develop and maintain operational automation scripts to improve stability, monitoring, and repeatability.
- Support controlled automation initiatives (e.g. job scheduling, scripted maintenance, validation support activities) where aligned with operational needs and compliance.
- Use PowerShell and scripting to automate routine tasks, monitoring, and administrative actions.
- Prepare and maintain automated jobs and scheduled tasks supporting application operations.
- Demonstrate working knowledge of databases (Oracle, SQL) relevant to laboratory applications.
- Support virtual machine (VM) environments, including VM build and configuration.
- Maintain validated VM images (experience in VM image creation is a strong advantage).
- Create and maintain technical documentation, operational procedures, and system descriptions.
- Support preparation of validation and audit documentation.
- Produce KPIs, operational metrics, and service reports related to system availability and performance.
Requirements
- Experience providing Level 2 / Level 3 operational support for enterprise applications.
- Working knowledge of GxP, data integrity, and internal quality requirements.
- Familiarity with Computer System Validation (CSV) activities including IQ, OQ, PQ execution.
- Understanding of GAMP 5, 21 CFR Part 11, and EU Annex 11 principles.
- Experience with incident, change, problem, and exception management processes.
- Ability to perform root cause analysis and contribute to CAPA processes.
- Technical expertise in laboratory applications such as Empower, NuGenesis, LabSolutions.
- Experience supporting regulated laboratory systems (e.g. CDS, SDMS, instrument control software).
- Proficiency in PowerShell and scripting for automation tasks.
- Working knowledge of databases (Oracle, SQL) relevant to laboratory applications.
- Experience supporting virtual machine (VM) environments including build and configuration.
- Ability to create and maintain technical documentation, operational procedures, and system descriptions.
Nice to Have
- Experience in VM image creation.
- Experience in regulated QC and GxP environments.
- Experience supporting audits and inspections in a GxP context.
- Experience coordinating software upgrades and lifecycle decisions with central teams and sites.
- Experience interfacing with application vendors for troubleshooting and best practices.
Additional Information
- Position based in Barcelona, Spain.
- Supports Eurofins BioPharma Product Testing business.
- Works within a globally distributed team.
- Collaborates with QA, CSV, Infrastructure, vendors, and business stakeholders.
