Analytical Validation Specialist IV

Job Description: 

Analytical Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. 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 right first time performance.

 

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of analytical equipment. 

• Drive/own the validation plans and execution of analytical equipment changes and process improvements.

• Execution of  Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.

• Own all forms of TW records including CC/CAPA/Deviations to support project completion.

• Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.

• Review analytical equipment, manuals, and devise validation plans

• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.

• Analytical Equipment Ownership

• Identify Quality Issues, involve stakeholders, drive to completion/resolution

• Participate on Risk Assessments

• Review/Approve Commissioning Qualification Validation Documents

• Looking for exposure to Kneat Validation.