Sr QA Validation Specialist

Regeneron Pharmaceuticals
Limerick, Munster, Ireland
Full Time
On Site
Senior
EUR 54,200 – 88,400
Bachelor Degree
Science & Research Healthcare Life Sciences

Posted 2 months ago

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Excellent 4.7

Job summary

The Senior QA Validation Specialist at Regeneron oversees equipment qualification, maintains compliance with regulatory standards, manages validation projects, and supervises junior staff within a highly regulated pharma/biotech environment.

Responsibilities

The Senior QA Validation Specialist will supervise end-to-end equipment qualification processes and ensure compliance with manufacturing standards and regulatory requirements. They will also manage projects, lead investigations into deviations, and provide guidance to less experienced team members.

Qualifications

change control data integrity deviation investigation project management quality assurance regulatory compliance risk management SOP troubleshooting validation

Candidates must hold a BS/BA in Engineering, Chemistry, or Life Science with at least 5-8 years of experience in a highly regulated environment. Expert knowledge of EU Annex 11, FDA 21 CFR Part 11, and site change control processes is required.

English

Benefits

  • Annual bonuses
  • Incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Insurance benefits
  • Paid time off
  • Family support benefits

Company

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

linkedin
Biotechnology
Location
Limerick, Munster, Ireland

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Excellent 4.7
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