Senior QA Validation Lead – GMP Compliance

Regeneron Pharmaceuticals, Inc

Munster

On-site

EUR 54,200 - 88,400

Full time

14 days+

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Benefits offered by this job

Annual bonuses or incentive plans
Health and wellness programs
Insurance benefits (medical, dental, vision, life)
Paid time off

Job summary

Regeneron Pharmaceuticals, Inc is seeking a Senior QA Validation Specialist to join their Quality Assurance team in Munster, Ireland. This role involves managing and executing validation protocols, ensuring compliance with regulations, and troubleshooting issues in a dynamic environment.

The ideal candidate will have a BS/BA in Engineering, Chemistry or Life Science and at least 5-8 years of experience in commissioning and qualification of large-scale process equipment. Regeneron offers a comprehensive total rewards package.

Qualifications

  • 5 – 8+ years of proven experience in Commissioning / Qualification.
  • Experience with Large Scale Process equipment.

Responsibilities

  • Generate, execute and review qualification and validation protocols.
  • Analyse results and determine acceptability against criteria.
  • Investigate problems and recommend solutions.
  • Review change controls, SOPs, and related documentation.
  • Manage projects and prepare status reports.

Skills

Commissioning / Qualification experience
Ability to work independently
Ability to communicate with transparency
Effective time management skills

Education

BS/BA in Engineering, Chemistry or Life Science

Job description

Regeneron Pharmaceuticals, Inc is seeking a Senior QA Validation Specialist to join their Quality Assurance team in Munster, Ireland. This role involves managing and executing validation protocols, ensuring compliance with regulations, and troubleshooting issues in a dynamic environment.

The ideal candidate will have a BS/BA in Engineering, Chemistry or Life Science and at least 5-8 years of experience in commissioning and qualification of large-scale process equipment. Regeneron offers a comprehensive total rewards package.

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