Computer System Validation Specialist

Overview GxP Associates is a rapidly expanding talent and workforce solutions company specializing in the pharmaceutical, biotechnology, and medical device industries. By providing engineering, quality, validation, regulatory, and IT professionals, we help organizations navigate compliance and execute critical projects in regulated environments. With a focus on integrity, industry expertise, and speed, we connect exceptional talent with leading life sciences companies. Our tailored staffing solutions ensure long-term value for clients, consultants, and partners while fostering growth and success. Position: GxP IT Systems Support / CSV Technical Location: On-Site in FL Responsibilities GxP/CSV execution for computerized systems (laboratory and manufacturing support systems) Configuration and documentation of software specifications IT and instrument support, including system administration, instrument/system troubleshooting, evidence collection, SOP upkeep, user/account provisioning and backup and restore activities The GxP IT Systems Support / CSV Technical Contractor provides hands-on IT support for computerized systems used in GxP operations at the Coral Springs site. This role focuses on system administration, technical troubleshooting (including vendor coordination), maintenance of configuration specifications, and drafting/updating site IT SOPs. The contractor partners with Quality/CSV to help maintain the validated state of systems by implementing and documenting controlled technical changes in accordance with site procedures and regulatory expectations. Essential Duties and Responsibilities Serve as the IT technical point of contact (SME) for assigned GxP computerized systems (e.g., laboratory and manufacturing support systems), ensuring availability, reliability, and compliance-aligned configuration. Perform system administration tasks, including user/account provisioning and periodic access reviews; role/privilege configuration; audit trail enablement/verification; time synchronization checks; and controlled parameter settings per approved specifications. Coordinate troubleshooting and resolution of system issues by engaging internal IT teams and reaching out to system vendors for triage, root-cause investigation, patches/hotfixes, and service requests; document incident details and outcomes per site procedures. Draft, update, and maintain Configuration Specifications (CS), system build/restore instructions, and other technical documentation that defines approved system settings and architecture for the site. Draft, update, and maintain site IT SOPs and work instructions related to GxP system administration (e.g., account management, backup/restore, audit trails, cybersecurity controls, patching, and disaster recovery), ensuring alignment with site governance. Manage and execute backups, restores, and disaster recovery activities for assigned systems (including periodic verification/testing) and ensure backup schedules and retention meet approved requirements. Support controlled technical changes through the site Quality Management System (QMS): initiate/execute IT tasks under approved change controls, provide impact/risk input as requested, and ensure evidence is captured for configuration changes. Implement and maintain baseline security controls for servers/workstations hosting GxP systems (e.g., endpoint protection, hardening settings, account policies) in coordination with site cybersecurity standards and approved system constraints. Plan and perform system and infrastructure upgrades (hardware/software) for assigned systems in coordination with vendors, operations, and QA/CSV; ensure technical readiness, rollback planning, and documentation updates. Qualifications Education & Experience Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field (or equivalent relevant experience). Minimum of 5 years’ experience supporting GxP-regulated IT systems (system administration and technical remediation) in a pharmaceutical/biotech or similarly regulated environment. Hands-on experience with vendor coordination, incident troubleshooting, and controlled change execution in a regulated setting. Working knowledge of GxP principles, data integrity expectations, and applicable regulations/standards (e.g., FDA 21 CFR Part 11; familiarity with GAMP 5 is a plus). Strong documentation skills, including authoring/updating configuration specifications and IT SOPs. Ability to manage multiple priorities, communicate clearly with technical and non-technical stakeholders, and work effectively on-site. #J-18808-Ljbffr