Job Title:
Experience: 3-5 Years
Job Summary:
The Senior IT Administrator will be responsible for managing and supporting the IT infrastructure, systems, and applications critical to bioanalytical operations within a GLP/GxP-compliant CRO. The role ensures high availability, compliance, and performance of IT services supporting regulated lab environments, including LIMS, chromatography software, and instrument data acquisition systems.
Infrastructure & System Support
- Manage and maintain lab-related IT infrastructure including servers, workstations, storage, and backup systems.
- Administer Windows Server environments, Active Directory, Group Policies, and file/print services.
- Ensure uptime and performance of systems supporting LC-MS/MS, HPLC, and other analytical instruments.
GxP & Compliance
- Ensure IT systems supporting bioanalytical operations meet
GxP, GLP, and FDA 21 CFR Part 11
compliance requirements. - Support audits and inspections by providing IT-related documentation, access logs, validation records, and system controls.
- Assist in Computer System Validation (CSV) and Data Integrity initiatives as per ALCOA+ principles.
Application & Lab Systems Support
- Provide L2/L3 support for laboratory applications such as
LIMS
, Analyst
, Thermo
, LabSolutions
, or equivalent. - Coordinate with instrument vendors and internal QA/RA for software upgrades, patches, and validation.
- Manage user access and security configurations for lab applications and instruments.
Data & Backup Management
- Oversee automated and manual backup processes for lab-generated data, ensuring integrity and retrievability.
- Ensure secure, compliant storage of analytical and raw data per regulatory retention policies.
User & IT Operations Support
- Act as the primary IT point of contact for lab users and scientific staff.
- Troubleshoot lab connectivity, software, printing, and data access issues.
- Provide training and guidance on compliant IT practices within lab operations.
Documentation & Change Control
- Create and maintain SOPs, user guides, validation protocols, and IT system documentation.
- Participate in Change Control, Deviation, and CAPA processes involving IT systems.
Key Skills & Competencies:
- Strong understanding of
bioanalytical workflows
and regulated lab environments. - Hands-on expertise in Windows OS, Active Directory, networking, data backup, and IT security.
- Experience supporting
regulated lab software (LIMS, chromatography systems)
. - Familiarity with
Computer System Validation (CSV)
, GAMP 5
, and data integrity
concepts. - Good problem-solving and communication skills.
- Ability to work under audit-ready, regulated environments.