Sr QA Validation Specialist

Regeneron Ireland; Limerick; On-site; EUR 54,000 - 88,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, -

Job summary

Regeneron Ireland in Raheen, Limerick is seeking a Senior QA Validation Specialist to join our Quality Assurance team. You will lead end-to-end qualification activities and support a 365 inspection readiness program.

The role requires 5–8+ years in pharma/biotech, strong change controls, data integrity awareness, and knowledge of EU Annex 11 and FDA 21 CFR Part 11. You will mentor staff and collaborate across departments to maintain regulatory compliance.

Qualifications

• BS/BA in Engineering, Chemistry or Life Science and 5–8+ years’ proven experience in the field preferred.
• SME experience in a highly regulated environment (pharma/biotech/medical devices) in audits.
• Strong background in site change controls, risk management and data integrity initiatives.

Responsibilities

• Supervising end‑to‑end qualification processes to ensure equipment fits for intended use.
• Fostering and implementing quality culture and manufacturing standards.
• Scheduling, executing, reviewing and approving qualification activities.
• Assessing change controls and deviations for regulatory impact.
• Investigating problems and proposing improvements.
• Reviewing deviation notifications, investigations, and corrective actions.
• Coordinating with departments and contractors to complete validation tasks.
• Managing and driving projects and mentoring staff.
• Communicating clearly and meeting scope/delivery commitments.
• Demonstrating knowledge of Data Integrity and project balancing.

Skills

QA validation

Regulatory compliance

Change control

Data integrity

Project management

Team leadership

GxP knowledge

Education

BS/BA in Engineering, Chemistry or Life Science

Job description

Build our future together: 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.

Location: Raheen, Limerick Some travel may be required.

What you’ll do:

• Supervising the end‑to‑end qualification process ensuring each piece of equipment fits for the intended use that contribute to 365 inspection readiness program
• Following, fostering and implementing a quality culture and other company manufacturing standards, policies and procedures
• Scheduling, executing, reviewing and approving qualification activities
• Assessing executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
• Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements
• Reviewing, editing, and approving deviation notifications, deviation investigations and corrective actions, change controls, SOPs, reports and other documentation
• Coordinating with other departments and outside contractors/vendors to complete validation tasks
• Managing and driving projects
• Supervising, providing direction and assigning work to less experienced full‑time employees (e.g. validation specialists) and/or contingent workers to meet goals and deadlines
• Ability to work independently or as part of a team
• Strong knowledge and understanding of the equipment used for QC analysis and operations
• Ability to communicate with transparency
• Meets commitments on scope and on time
• You have strong knowledge of Data Integrity
• Ability to prioritize and balance multiple tasks simultaneously
• You have project management experience

Requirements:

• BS/BA in Engineering, Chemistry or Life Science and requires at least 5 – 8+ years’ proven experience within the field preferred; may substitute relevant experience for education.
• Previous experience as a SME in a highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits.
• Strong background in site change controls, risk management and data integrity initiatives/programs.
• You have expert knowledge of EU annex 11 and FDA 21 CFR Part 11.

Benefits:

• 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
• Family support benefits

Salary Range (annually) €54,200.00 - €88,400.00

In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

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 other locations, additional information will be provided during the recruitment process.

Let’s find out if we’re a fit: Thrive today. Grow tomorrow.

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.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award‑winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.