GxP IT Systems CSV Specialist

Compunnel, Inc.; Town of Florida (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

Compunnel, Inc. is seeking a GxP IT Systems Support / CSV Technical Contractor to provide hands-on IT support for their GxP operations. The contractor will be responsible for system administration, technical troubleshooting, and managing configuration specifications.

Qualified candidates must have at least 5 years of experience supporting IT systems in regulated environments, strong knowledge of GxP principles, and excellent documentation skills. This role coordinates closely with Quality and CSV teams, ensuring compliance with regulatory requirements.

Qualifications

• 5+ years supporting GxP-regulated IT systems in pharmaceutical environments.
• Hands-on experience with technical troubleshooting and change management.
• Strong knowledge of FDA 21 CFR Part 11 regulations.

Responsibilities

• Serve as the IT technical Subject Matter Expert (SME) for GxP systems.
• Perform system administration activities including user provisioning.
• Coordinate troubleshooting of system issues with vendors.
• Document incidents and corrective actions per site procedures.
• Draft and maintain Configuration Specifications and technical documentation.

Skills

System administration

Technical troubleshooting

Vendor coordination

GxP principles

Technical documentation

Organizational skills

Communication skills

Education

Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field

Job description

Compunnel, Inc. is seeking a GxP IT Systems Support / CSV Technical Contractor to provide hands-on IT support for their GxP operations. The contractor will be responsible for system administration, technical troubleshooting, and managing configuration specifications.

Qualified candidates must have at least 5 years of experience supporting IT systems in regulated environments, strong knowledge of GxP principles, and excellent documentation skills. This role coordinates closely with Quality and CSV teams, ensuring compliance with regulatory requirements.