Laboratory GxP Systems Specialist II at Replimune Group in Milton Park

Job description

Overview Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. Summary of job description: 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. Key responsibilities: Laboratory Computerized Systems Administration 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. Quality and Compliance Activities 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. Vendor and Project Management 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. Training and Continuous Improvement 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. Other Responsibilities 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 continuity. Educational Requirements Bachelor's degree in Life Sciences, Chemistry, Biotechnology, Engineering, Computer Science, Information Systems, or related discipline required. Advanced degree or relevant professional certi