Senior QA Validation Specialist - Accelerate Life Sciences

BioSpace; Ireland (WV); On-site; USD 61,000 - 99,000; Full time

Job summary

Regeneron is seeking a Senior QA Validation Specialist to join our Quality Assurance team in Ireland. The role involves generating, executing and reviewing qualification and validation protocols, analyzing testing results, and coordinating with contractors to complete validation tasks. Some travel may be required.

You will need a BS/BA in Engineering, Chemistry or Life Science and at least 5–8 years of commissioning/qualification experience with large-scale process equipment. Thrive today.

Qualifications

• BS/BA in Engineering, Chemistry or Life Science.
• 5–8+ years proven experience in Commissioning / Qualification with Large Scale Process equipment.
• Experience generating, executing and reviewing qualification and validation protocols and summary reports.

Responsibilities

• Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analysing the results of testing and determines the acceptability of results against pre-determined criteria
• Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviewing, editing and approval deviation notifications, deviation investigations, and corrective actions
• Reviewing and approval of change controls, SOPs, reports and other documentation
• Coordinating with other departments or outside contractors/vendors to complete validation tasks
• Managing projects and prepares status reports
• Providing oversight to contingent workers may be a requirement

Education

BS/BA in Engineering, Chemistry or Life Science

Job description

Regeneron is seeking a Senior QA Validation Specialist to join our Quality Assurance team in Ireland. The role involves generating, executing and reviewing qualification and validation protocols, analyzing testing results, and coordinating with contractors to complete validation tasks. Some travel may be required.

You will need a BS/BA in Engineering, Chemistry or Life Science and at least 5–8 years of commissioning/qualification experience with large-scale process equipment. Thrive today.