JOB DESCRIPTION:

CSV, Analytical and Enterprise Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, Administration of systems and applications, and decommissioning activities as appropriate. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery, and first-time performance.

Responsibilities:

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of CSV, analytical and enterprise systems/applications.
• Review and Approval of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Assist in generating User Requirements Specification Documentation, Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Prepare Administration and Configuration specification document with support from vendor user manual.
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets, and installations.
• Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems.
• Create and or Revise SOPs for CSV, Analytical and enterprise systems, and applications.
• Participating in Risk Assessments.
• Review/Approve Commissioning Qualification Validation Documents.
• Perform other duties as assigned.

Requirements:

• Bachelor of Science - Science related discipline or relevant experience in the field.
• Experience 5-10 Years.

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of CSV, analytical and enterprise systems/applications.
• Review and Approval of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Assist in generating User Requirements Specification Documentation, Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Prepare Administration and Configuration specification document with support from vendor user manual.
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets, and installations.
• Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems.
• Create and or Revise SOPs for CSV, Analytical and enterprise systems, and applications.
• Participating in Risk Assessments.
• Review/Approve Commissioning Qualification Validation Documents.
• Perform other duties as assigned