Senior QA Validation Specialist

Regeneron; Limerick; On-site; EUR 54,200 - 88,400; Full time

Job summary

Regeneron is seeking a Senior QA Validation Specialist to join their Quality Assurance team in Limerick. This role involves generating, executing, and reviewing validation protocols while ensuring compliance with industry regulations. Candidates should possess a BS/BA in Engineering, Chemistry, or Life Sciences and have substantial experience (5–8+ years) in relevant fields.

The position offers a salary range of €54,200 - €88,400 annually, and some travel may be required. Regeneron values diversity and inclusion in the workplace.

Qualifications

• At least 5–8+ years of proven experience in commissioning/qualification with large-scale process equipment.

Responsibilities

• Generating and reviewing qualification and validation protocols.
• Analyzing testing results against criteria.
• Investigating problems and recommending solutions.

Skills

Commissioning/Qualification

Time Management

Teamwork

Education

BS/BA in Engineering, Chemistry or Life Sciences

Job description

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases.

Senior QA Validation Specialist, Quality Assurance team.

Location

Raheen, Limerick. Some travel may be required.

Responsibilities

• 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.
• Analyzing the results of testing and determining the acceptability of results against pre‑determined criteria.
• Investigating and troubleshooting problems, and recommending solutions or improvements.
• Reviewing, editing, and approving deviation notifications, deviation investigations, and corrective actions.
• Reviewing and approving change controls, SOPs, reports and other documentation.
• Coordinating with other departments or outside contractors/vendors to complete validation tasks.
• Managing projects and preparing status reports.
• Providing oversight to contingent workers, if required.

Environment & Physical Rhythms

• Ability to work independently or as part of a team.
• Ability to communicate with transparency.
• Demonstrate respectful behaviour at all times.
• Gather and organise information.
• Meet commitments on scope and on time.
• Follow directions and perform well‑defined tasks.
• Effective time‑management skills.
• Seek to identify continuous improvement needs.

Qualifications

• BS/BA in Engineering, Chemistry or Life Sciences.
• At least 5–8+ years of proven experience in commissioning/qualification with large‑scale process equipment.

Compensation

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, reasonable accommodation will be provided to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.