Senior QA Validation Specialist

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 54,200 - 88,400; Full time

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

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Senior QA Validation Specialist to join our Quality Assurance team.

This position offers the opportunity to contribute to a fast‑growing, science‑driven organisation making a meaningful difference to patients worldwide.

When & where:

• Location: Raheen, Limerick
• Some travel may be required.

What you’ll do:

• 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

The environment and physical rhythms of this role:

• Ability to work independently or as part of a team
• Ability to communicate with transparency
• Demonstrate respectful behaviour at all times
• Gathers and organises information
• Meets commitments on scope and on time
• Follows directions, performs well‑defined tasks
• Effective time management skills
• Seeks to identify continuous improvement needs

Let’s find out if we’re a fit:

• To be considered for this opportunity you must have a BS/BA in Engineering, Chemistry or Life Science and requires at least 5 – 8+ years’ proven experience in Commissioning / Qualification experience with Large Scale Process equipment

Salary Range (annually)

€54,200.00 - €88,400.00

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.