Laboratory GxP Systems Administrator

Location: Milton Park, United Kingdom; 5-day on-site expectation.

Company

hirify.global develops oncolytic immunotherapies designed to activate durable systemic anti-tumor responses and transform cancer treatment.

What you will do

• Administer laboratory computerized systems, including user access, configurations, workflows, roles, permissions, reporting, and periodic access reviews.
• Maintain system inventories, asset records, software versions, backups, archives, and lifecycle documentation.
• Coordinate installations, upgrades, patches, maintenance, monitoring, troubleshooting, and issue resolution with IT, vendors, and stakeholders.
• Support data integrity, cybersecurity, disaster recovery, validation, compliance assessments, audit readiness, and regulatory inspections.
• Coordinate vendors, consultants, and external validation contractors, and participate in projects covering implementation, testing, validation, qualification, FAT, SAT, and commissioning.
• Develop training and controlled documentation, support investigations, and drive continuous improvement in system administration and computer system validation.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, Engineering, Computer Science, Information Systems, or a related discipline.
• 5–8 years of experience administering computerized systems in a regulated GxP environment.
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, Windows and Active Directory environments, laboratory systems, software lifecycle management, periodic review, and supplier assessment.
• Experience with change control, deviations, CAPAs, and quality management systems.
• Strong technical writing, communication, organization, stakeholder management, problem-solving, attention to detail, independent work, and cross-functional collaboration skills.
• Ability to work in accordance with SOPs, cGMP, GDocP, quality, safety, training, and qualification requirements, including after-hours support when required.

Nice to have

• Advanced degree or relevant professional certifications.
• Experience with viewLinc, Empower, SoftMax Pro GxP, PharmSpec, BlueMountain Regulatory Asset Manager, LIMS, QuantStudio Design and Analysis, and/or JMP.
• Experience with Computer System Validation and data integrity principles.
• Knowledge of pharmaceutical, biotechnology, or cell and gene therapy laboratory operations.
• Experience supporting cloud-hosted and SaaS-based GxP applications.
• Experience assessing and implementing software updates and cybersecurity patches in a validated environment.

Culture & Benefits

• Mission-driven work focused on transforming cancer treatment and improving patient outcomes.
• Values include collaboration, boldness, commitment, and candid communication.
• Competitive and forward-looking total rewards program.
• On-site work at Milton Park with participation in after-hours support when needed for business continuity.