CSV Technical Specialist

JOB SUMMARY

The GxP IT Systems Support / CSV Technical Contractor is responsible for providing hands-on IT support for computerized systems used in GxP operations. This role focuses on system administration, technical troubleshooting, vendor coordination, maintenance of configuration specifications, and development of site IT SOPs. The contractor collaborates closely with Quality and CSV teams to maintain the validated state of systems by implementing and documenting controlled technical changes in alignment with site procedures and regulatory requirements. Key Responsibilities

• Serve as the IT technical Subject Matter Expert (SME) for assigned GxP computerized systems, ensuring system availability, reliability, and compliance-aligned configuration.
• Perform system administration activities, including user and account provisioning, periodic access reviews, role and privilege configuration, audit trail enablement and verification, time synchronization checks, and controlled parameter settings.
• Coordinate troubleshooting and resolution of system issues by collaborating with internal IT teams and external vendors for root-cause investigations, patches, hotfixes, service requests, and technical remediation.
• Document incidents, investigations, corrective actions, and outcomes in accordance with site procedures.
• Draft, update, and maintain Configuration Specifications (CS), system build and restore instructions, and technical documentation defining approved system settings and architecture.
• Develop and maintain site IT SOPs and work instructions related to account management, backup and restore procedures, audit trail management, cybersecurity controls, patching activities, and disaster recovery processes.
• Manage and execute system backups, restores, and disaster recovery activities, including periodic verification and testing.
• Support controlled technical changes through the site Quality Management System (QMS), including executing approved change controls, providing impact and risk assessments, and capturing evidence for configuration changes.
• Implement and maintain baseline security controls for servers and workstations hosting GxP systems in coordination with site cybersecurity standards.
• Plan and perform hardware and software upgrades for assigned systems, ensuring technical readiness, rollback planning, proper documentation updates, and coordination with vendors, operations, and QA/CSV teams.
• Provide technical support to Quality and CSV teams by supplying system information and evidence required for validation deliverables, assessments, investigations, and CAPA activities. Required Qualifications
• Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field, or equivalent relevant experience.
• Minimum of 5 years of experience supporting GxP-regulated IT systems within pharmaceutical, biotech, or similarly regulated environments.
• Hands-on experience with system administration, technical troubleshooting, vendor coordination, and controlled change management in regulated environments.
• Strong knowledge of GxP principles, data integrity requirements, and

FDA 21 CFR

Part 11 regulations.

• Strong technical documentation skills, including experience authoring and maintaining Configuration Specifications, IT SOPs, and technical procedures.
• Excellent organizational, communication, and multitasking abilities with the capability to work effectively with both technical and non-technical stakeholders. Preferred Qualifications
• Familiarity with GAMP 5 guidelines and computerized system validation best practices.
• Experience supporting laboratory and manufacturing systems in regulated pharmaceutical environments. Certifications
• Relevant IT, cybersecurity, or validation certifications are considered a plus.