Sr QA Validation Specialist (Oversight)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Join our Quality Assurance team as a Sr. QA Validation Specialist and support validation of equipment, utilities, software, cleaning, and sterilization processes at our Rensselaer, New York facility in accordance with regulatory requirements.

About the role

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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
• Investigates and troubleshoots problems which occur during validations and determines solutions or recommendations for changes and/or improvements
• Coordinates with functional departments 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
• Develops tracking mechanisms for validation activity completion and prepares status reports
• Presents validation project and program status reports to senior management on a routine basis
• Ensures that validation status is maintained for equipment and software used in commercial and clinical manufacturing
• Stays current with industry trends and regulatory requirement updates, communicating them to teams
• May present at both internal and external (regulatory) audits

Requirements

• B.S. in life sciences or related field; may substitute proven experience for education requirement
• QA Validation Specialist: 4+ years of experience
• Sr. QA Validation Specialist: 6+ years of experience

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture, and well-being programs (including physical & mental health)
• 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
• Family support benefits

Pay

Salary Range (annually): $67,400.00 - $128,700.00

Schedule

Monday-Friday, 8am-4:30pm