Senior QA Validation Specialist (Biotech)

Location: Raheen, Limerick, Ireland; onsite work is expected and some travel may be required.

Company

hirify.global is a biotechnology company that develops and commercializes medicines for serious diseases.

What you will do

• Supervise end-to-end equipment qualification activities and ensure equipment is fit for intended use.
• Schedule, execute, review, and approve qualification activities supporting inspection readiness.
• Assess change controls and deviations for impact on the qualified state and regulatory compliance.
• Review and approve deviation investigations, corrective actions, SOPs, reports, and related documentation.
• Investigate validation issues, recommend improvements, and coordinate tasks with departments, contractors, and vendors.
• Manage validation projects and assign work to validation specialists and contingent workers.

Requirements

• BS/BA in Engineering, Chemistry, or Life Science, or equivalent relevant experience.
• At least 5–8 years of relevant experience.
• Experience as a subject matter expert in a highly regulated pharma, biotech, or medical-device environment.
• Experience with internal and external regulatory audits, site change controls, risk management, and data integrity initiatives.
• Expert knowledge of EU Annex 11 and FDA 21 CFR Part 11.
• Strong knowledge of equipment used for QC analysis and operations, with the ability to manage multiple priorities independently and collaboratively.

Culture & Benefits

• Quality-focused environment supporting a 365-day inspection readiness program.
• Work independently and collaboratively with transparent communication and accountability for commitments.
• Competitive total rewards may include bonuses, equity awards, pension or retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Inclusive workplace with reasonable accommodations available where required.