GxP Lab Systems Specialist II — Compliance & Validation

Replimune; United Kingdom; Remote; GBP 55,000 - 75,000; Full time

Job summary

Replimune is seeking a Laboratory GxP Systems Administrator to own the administration, validation and compliance of laboratory systems in a regulated environment. This role is based at Milton Park with a five‑day on‑site expectation.

You will manage access controls, inventories, change controls, audits, data integrity, cybersecurity and vendor coordination to ensure systems stay validated and secure within a fast‑growing biotherapeutics setting.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biotechnology, Engineering, Computer Science, Information Systems, or related discipline required.
• Advanced degree or relevant professional certifications desirable.

Responsibilities

• 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 continuity.

Skills

GxP systems experience

Regulatory knowledge

Technical writing

Stakeholder management

Education

BSc Life Sciences / related

Advanced degree desirable

Tools

viewLinc

Empower

SoftMax Pro GxP

PharmaSoft/Reg Asset Manager

LIMS

JMP

Job description

Replimune is seeking a Laboratory GxP Systems Administrator to own the administration, validation and compliance of laboratory systems in a regulated environment. This role is based at Milton Park with a five‑day on‑site expectation.

You will manage access controls, inventories, change controls, audits, data integrity, cybersecurity and vendor coordination to ensure systems stay validated and secure within a fast‑growing biotherapeutics setting.