QA Validation Associate - Cleaning & Compliance

Regeneron Pharmaceuticals; City of Troy (NY); On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking an Associate QA Validation Specialist to validate and qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards. This on-site role focuses on the cleaning validation team and covers writing and reviewing protocols, data analysis, deviation handling, and cross-functional collaboration.

The position requires a BS/BA in Engineering, Chemistry, or Life Sciences with 0–2 years of experience for

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences.

Responsibilities

• Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Reviews, edits and approves deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
• Manages projects and prepares status reports.
• May present at both internal and external (regulatory) audits
• Other duties assigned by management.
• Some travel may be required.

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Job description

Regeneron Pharmaceuticals is seeking an Associate QA Validation Specialist to validate and qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards. This on-site role focuses on the cleaning validation team and covers writing and reviewing protocols, data analysis, deviation handling, and cross-functional collaboration.

The position requires a BS/BA in Engineering, Chemistry, or Life Sciences with 0–2 years of experience for