Lab system validation engineer (Onsite)

As a Lab Computing Support Specialist, you will manage the lifecycle of laboratory systems, including implementation, validation, maintenance, upgrades, patching, backup, archival, and decommissioning activities.

• Provide technical support for laboratory software systems, instrument integration platforms, and analytical instruments while troubleshooting software, hardware, and connectivity issues.
• Persistently partner with laboratory, QA, and IT teams to ensure compliance with GxP, GLP, GMP, Computer System Validation (CSV), and data integrity requirements.
• Coordinate with vendors for system installations, maintenance, upgrades, issue resolution, and service management while ensuring compliance with regulatory and operational requirements.
• Support audits, inspections, change management, deviation management, CAPA activities, documentation updates, and continuous improvement initiatives across laboratory systems.

Qualifications

• Bachelor's degree in Life Sciences, Information Technology, Engineering, Computer Science, or a related discipline.
• Experience supporting laboratory systems within pharmaceutical, biotechnology, or other regulated Life Sciences environments.
• A strong understanding of GxP, GLP, GMP, data integrity principles, and regulatory requirements.
• Hands-on experience with Computer System Validation (CSV), SDLC, and validation lifecycle activities.
• Experience supporting laboratory software applications, analytical instruments, and instrument integration platforms.
• Knowledge of laboratory workflows and familiarity with analytical instruments such as HPLC, GC, spectrophotometers, or similar laboratory technologies.
• Experience with user administration, backup and recovery processes, software upgrades, patch management, and system maintenance activities.
• A working knowledge of ticketing and service management tools such as ServiceNow, Remedy, or similar platforms.
• Experience with deviation management, change control, CAPA processes, and audit support activities.
• Strong troubleshooting, communication, technical documentation, and stakeholder management skills.

Preferred Qualifications

• Experience supporting regulated laboratory environments within pharmaceutical research, development, manufacturing, or quality operations.
• Knowledge of Computer System Validation deliverables and regulatory frameworks including FDA 21 CFR Part 11, GAMP 5, and CSV best practices.
• Experience supporting laboratory system onboarding, offboarding, configuration management, and data archival processes.
• Experience participating in regulatory inspections, audit readiness activities, and remediation programs.
• Familiarity with Jira, ServiceNow, or other IT service management and workflow platforms.
• Experience working within Agile delivery environments.
• Exposure to automation, AI-enabled support solutions, or digital transformation initiatives in laboratory operations.