CSV Analytical and Enterprise Validation Specialist - Portsmouth, NH

Job Description

Job DescriptionJob Title: CSV, Analytical, and Enterprise Validation Specialist IV
Experience Required: 5–10 years
Education: Bachelor of Science in a science-related discipline or relevant field experience

Job Description:
The CSV, Analytical, and Enterprise Validation Specialist IV will lead validation activities, including software updates, new system introductions, system/application administration, and decommissioning activities as needed. This role collaborates closely with Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to ensure compliance and support quality, timely delivery, and right-first-time performance.

Key Responsibilities:

• Serve as a Subject Matter Expert (SME) for Quality Control, Manufacturing, and other departments regarding the design, operation, and troubleshooting of CSV, analytical, and enterprise systems/applications.

• Review and approve Installation Qualifications (IQ) and Operational Qualifications (OQ); draft Performance Qualifications (PQ) as needed.

• Assist in the creation of User Requirements Specifications, Electronic Records/Electronic Signatures documentation, Data Integrity Risk Assessments, and Audit Trail Risk Assessments.

• Prepare Administration and Configuration Specification documents using vendor user manuals for support.

• Manage procurement of analytical equipment, ensuring compliance with specifications, quotes, budgets, and installation requirements.

• Perform user and application software administration on enterprise systems; handle complex troubleshooting tasks requiring initiative and sound judgment.

• Create and revise SOPs related to CSV, analytical, and enterprise systems/applications.

• Participate in Risk Assessments.

• Review and approve Commissioning, Qualification, and Validation documents.

• Perform other duties as assigned.