Senior Lab System Support Engineer

We are seeking a Senior Lab System Support Engineer to support laboratory operations within a regulated pharmaceutical environment. The ideal candidate will have strong experience in laboratory system lifecycle management, vendor management, and laboratory business processes, with a solid understanding of GxP compliance requirements.

This role will be responsible for supporting laboratory systems, analytical instruments, system validation, vendor coordination, compliance activities, and day-to-day operational support for laboratory IT systems and instrument integration platforms., Lab System Lifecycle Management

• Manage the complete lifecycle of laboratory systems, including implementation, validation, maintenance, upgrades, and decommissioning.
• Ensure compliance with Software Development Life Cycle (SDLC), Computer System Validation (CSV), GxP, and regulatory requirements.
• Coordinate system upgrades, patching, backups, archival activities, and audit readiness efforts.
• Support onboarding and offboarding of laboratory systems.
• Manage backup, restoration, and disaster recovery activities for laboratory systems.

Laboratory Systems Support

• Provide first-level support for laboratory software systems and instrument integration platforms.
• Support user administration activities, including user creation, modification, and deactivation.
• Coordinate hardware-related issues with desktop support and infrastructure teams.
• Troubleshoot software and hardware issues associated with laboratory instruments and systems.
• Perform application software upgrades and maintenance on standalone and benchtop systems.
• Configure and maintain laboratory system environments and related infrastructure.

Vendor Management

• Serve as the primary point of contact for laboratory system vendors.
• Coordinate installations, maintenance activities, upgrades, and issue resolution.
• Manage vendor deliverables and ensure compliance with service-level agreements (SLAs).
• Escalate and track system hardware failures and maintenance-related issues.

Regulatory Compliance & Validation

• Ensure compliance with GLP, GMP, GxP, FDA regulations, and data integrity requirements.
• Support Computer System Validation (CSV) activities and maintain validated system states.
• Assist with audit preparation, audit responses, and regulatory inspections.
• Maintain audit trails, system documentation, and data archival processes.
• Update and maintain SOPs, work instructions, and system documentation.

Cross-Functional Collaboration

• Collaborate closely with Laboratory Operations, QA, IT, Infrastructure, and Validation teams.
• Participate in cross-functional meetings to improve laboratory workflows and system performance.
• Support investigations, deviations, change controls, CAPAs, and problem management activities.
• Act as a liaison between laboratory teams, vendors, and regulatory stakeholders.

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, Engineering, or related field.
• Experience supporting laboratory systems within pharmaceutical, biotechnology, or regulated life sciences environments.
• Strong understanding of laboratory system lifecycle management.
• Experience managing laboratory system vendors and external service providers.
• Knowledge of pharmaceutical laboratory business processes and regulatory requirements.
• Experience working within GxP-regulated environments.
• Understanding of Computer System Validation (CSV) principles and practices.
• Experience with ticketing systems such as ServiceNow, Remedy, or similar platforms.
• Strong troubleshooting and problem-solving skills.
• Excellent communication and stakeholder management skills.

Preferred Experience

• Experience supporting laboratory instruments such as:

• HPLC
• GC
• Spectrophotometers
• Analytical laboratory systems

• Experience with:

• GLP
• GMP
• GxP
• FDA regulations
• Data Integrity requirements

• Knowledge of:

• Change Management
• CAPA Management
• Deviation Management
• Problem Management
• Audit Readiness and Regulatory Compliance