Senior QA Validation Specialist

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.

When & Where:

• Location: Raheen, Limerick
• Some travel may be required.

What you'll do:

• 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 determining solutions or recommendations for changes and/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 may be a requirement.

The environment and physical rhythms of this role:

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

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 require at least 5-8+ years proven experience in commissioning / qualification experience with large scale process equipment.

Equal Opportunity Statement

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.

Salary Range (annually)

54,200.00 - 88,400.00