Sr QA Validation Specialist

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 54,000 - 88,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Senior QA Validation Specialist to join the Quality Assurance team. The role involves supervising end-to-end qualification processes for QC equipment, driving a quality culture and ensuring readiness for regulatory inspections.

You will coordinate validation activities, assess change controls and deviations, investigate issues, and collaborate with departments and vendors to deliver projects on time. On-site in Limerick with some travel.

Qualifications

• BS/BA in Engineering, Chemistry or Life Science.
• At least 5–8+ years’ proven experience within QA validation.
• SME in a highly regulated environment (pharma, biotech, medical devices) with internal and external regulatory audits.
• Strong background in site change controls, risk management and data integrity initiatives/programs.
• Expert knowledge of EU Annex 11 and FDA 21 CFR Part 11.

Responsibilities

• Supervising the end-to-end qualification process ensuring each piece of equipment fits for the intended use.
• 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 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.

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.

Where:

• 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

The environment and physical rhythms of this role:

• 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

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 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

Thrive today. Grow tomorrow.

#IRELIM #JOBSIEST #LI-Onsite #REGNIEQA

We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. 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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€54,200.00 - €88,400.00