Senior MSAT Engineer: Tech Transfer & Validation

Regeneron Pharmaceuticals; Valley (AL); On-site; USD 92,000 - 176,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Job summary

Regeneron Pharmaceuticals is seeking a Principal MSAT engineer to support internal and external drug substance manufacturing across modalities. Located in East Greenbush, NY, the role focuses on technology transfer, lifecycle documentation, and ongoing manufacturing support within a cGMP framework.

The successful candidate will lead cross-functional MSAT activities, mentor junior engineers, and define risk-based validation and change strategies while ensuring data integrity and compliance across

Qualifications

• BS/BA in engineering with 8+ years experience or MS with 7+ years or PhD with 2+ years
• Experience in technology transfer and process validation in pharma
• Knowledge of cGMP, data integrity and regulated documentation

Responsibilities

• Provide technical expertise for internal and external technology transfer of drug substance manufacturing processes
• Generate, review, and support documentation for technology transfer and lifecycle activities
• Provide technical support to manufacturing operations during start-up, engineering runs, validation, and routine manufacturing
• Lead problem-solving in process support and apply engineering principles
• Review batch records, automation recipes, SOPs, and change documentation
• Gather, trend, and analyze process data to support process understanding and monitoring
• Participate in investigations and deviations with root-cause analysis and corrective actions
• Collaborate in multi-functional teams to ensure timely MSAT task execution
• Ensure activities align with cGMP, data integrity, and safety standards
• Identify risks and propose mitigation strategies
• Lead workstreams for technology transfers or validation activities
• Provide mentorship to junior engineers
• Maintain transfer gap assessments and execution plans
• Define risk-based approaches for process validation and control strategies

Skills

Problem solving

Communication

Education

BS/BA in engineering

MS in engineering

PhD in engineering

Job description

Regeneron Pharmaceuticals is seeking a Principal MSAT engineer to support internal and external drug substance manufacturing across modalities. Located in East Greenbush, NY, the role focuses on technology transfer, lifecycle documentation, and ongoing manufacturing support within a cGMP framework.

The successful candidate will lead cross-functional MSAT activities, mentor junior engineers, and define risk-based validation and change strategies while ensuring data integrity and compliance across