Laboratory GxP Systems Specialist II

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The Laboratory GxP Systems Administrator is responsible for the administration, maintenance, compliance, and support of laboratory computerized systems used within a regulated GxP environment. The role serves as the primary liaison between laboratory users, Quality Assurance, IT, Validation, and system vendors to ensure laboratory systems remain secure, available, compliant, and maintained in a validated state.

This position is based in our Milton Park location and typically has a 5-day on-site expectation.

• Administer laboratory computerized systems, including user access management, system configuration, workflows, roles, permissions, reporting, and periodic access reviews.

• Maintain system inventories, asset records, software version information, backups, archives, and associated lifecycle documentation.

• Coordinate software installations, upgrades, patches, maintenance activities, and system monitoring, escalating issues and managing resolution with IT, vendors, and other stakeholders as required.

• Support system reliability, cybersecurity, data integrity, disaster recovery, and troubleshooting of laboratory applications and instrument software.

• Author, review, and support change controls, deviations, CAPAs, impact assessments, and other quality records associated with laboratory computerized systems.

• Support validation inventories, compliance assessments, audit and inspection readiness activities, and serve as a subject matter expert during internal audits and regulatory inspections.

• Coordinate activities performed by software vendors, consultants, and external validation contractors, including review of vendor documentation, release notes, service reports, and software lifecycle records.

• Participate in cross-functional projects involving laboratory systems and digital solutions, tracking deliverables, timelines, risks, and actions through implementation, testing, validation, and qualification activities, including FAT, SAT, commissioning, and qualification where applicable.

• Develop and deliver user training, provide guidance on compliance and data integrity requirements, and support the development and revision of SOPs, work instructions, and lifecycle management procedures.

• Drive continuous improvement initiatives related to laboratory computerized systems, system administration practices, and computer system validation processes.

• Ensure all activities are performed in accordance with SOPs, cGMP requirements, GDocP requirements, quality standards, and safety procedures.

• Maintain personal training compliance and qualification requirements for assigned responsibilities.

• Support laboratory and quality-related investigations involving computerized systems.

• Participate in after-hours support activities when required for business…