Principal MSAT Engineer: Tech Transfer & Process Validation

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks a Principal MSAT engineer to support technology transfer and lifecycle activities for drug substance manufacturing processes, mainly synthetic chemistry and peptides.

You will generate and review transfer documents, SOPs, and batch records, and provide technical support across startup, validation, and routine production. You will lead cross-functional teams, mentor junior engineers, identify risks, and justify validation approaches

Qualifications

• BS/BA in engineering with 8+ years experience; MS with 7+ years; PhD with 2+ years, or equivalent.
• Experience in technology transfer, process validation, and manufacturing support.
• Knowledge of biopharmaceutical manufacturing processes and regulatory documentation practices.

Responsibilities

• Generate, review, and support documentation for technology transfer and lifecycle activities.
• Provide technical support to manufacturing during start-up, engineering runs, validation, and routine manufacturing.
• Lead problem solving using engineering principles.
• Review batch records, automation recipes, SOPs, and change documentation.
• Gather and analyze process data for understanding and performance monitoring.
• Participate in investigations and deviation assessments and identify root causes and corrective actions.
• Work in multi-functional teams to support MSAT tasks.
• Ensure activities align with cGMP, data integrity, and safety standards.
• Identify technical risks and propose mitigation strategies.
• Lead defined workstreams for technology transfers or process validation.
• Provide technical mentorship to junior engineers.
• Define and justify risk-based approaches for process validation, control strategies, and change implementation.

Skills

Engineering knowledge

MSAT experience

cGMP knowledge

Data integrity

Cross-functional collaboration

Education

BS/BA in Engineering

MS in Engineering

PhD in Engineering

Job description

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks a Principal MSAT engineer to support technology transfer and lifecycle activities for drug substance manufacturing processes, mainly synthetic chemistry and peptides.

You will generate and review transfer documents, SOPs, and batch records, and provide technical support across startup, validation, and routine production. You will lead cross-functional teams, mentor junior engineers, identify risks, and justify validation approaches