Sr QA Validation Specialist

Limerick💼 Full-time💰 $54,200–$54,200🗓 2026-08-05 → 2026-09-26

Core

Supervise end-to-end qualification processes for equipment to ensure fit-for-purpose and support inspection readiness in a highly regulated manufacturing environment.

Role type

Senior QA Validation Specialist

Builds

Qualified state of equipment and validation documentation for life sciences manufacturing

Domain

Life Sciences / Biopharmaceuticals / Quality Assurance

Deliverable

Required skills

Qualification process management, Change control assessment, Deviation investigation, Data Integrity expertise, Risk management, EU Annex 11 knowledge, FDA 21 CFR Part 11 knowledge, Project management, Team leadership

Preferred skills

SME experience in regulatory audits, Equipment qualification expertise

Technologies

None explicitly listed

Responsibilities

Supervising end-to-end qualification processes, Assessing change controls and deviations, Investigating and troubleshooting problems, Reviewing and approving validation documentation, Coordinating with contractors/vendors, Managing validation projects, Supervising less experienced staff

Seniority

Senior, hands-on IC with team leadership

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About regeneron

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regu