Sr QA Validation Specialist (Oversight)

Regeneron Pharmaceuticals•Rensselaer, NY

8d•$67,400 - $128,700•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Sr. QA Validation Specialist, you will support validation of equipment, utilities, software, cleaning and sterilization processes at our facility in accordance with regulatory requirements by implementing company manufacturing standard policies and procedures. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Requires B.S in life sciences or related field; may substitute proven experience for education requirement
Sr. QA Validation Specialist: 6+ years of experience

Nice To Haves

QA Validation Specialist: 4 + years of experience
Level will be determined based on experience

Responsibilities

Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
Investigation and troubleshooting problems which occur during validations and determines solutions or recommendation for changes and/or improvements
Coordinates with functional department to resolve issues from validations
Reviews, edits and approves deviation notifications, deviation investigations and corrective actions
Coordinates with other departments or outside contractors/vendors to complete validation tasks
Develop tracking mechanism of validation activity completion for various projects and prepare status report
Present validation project and program status reports to senior management on a routine basis
Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing
Stays current with industry trends, regulatory requirement updates and communicating to teams
May present at both internal and external (regulatory) audits