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
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