Principal MSAT Engineer, Biopharma Tech Transfer

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); Sur place; USD 92 000 - 176 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a Principal MSAT engineer in East Greenbush, NY. You will provide technical leadership for technology transfer, process validation, and ongoing manufacturing support across multiple modalities.

You’ll work with Quality, Regulatory, and Manufacturing to ensure cGMP compliance and robust processes. You will mentor junior engineers, lead defined workstreams, and develop risk-based validation and control strategies.

Qualifications

• BS/BA in engineering with 8+ years of experience, or MS with 7+ years, or PhD with 2+ years.
• Experience in tech transfer, process validation, and CGMP environments.
• Strong analytical and problem-solving capabilities with data-driven mindset.

Responsabilités

• Provide technical expertise for internal and external technology transfer of drug substance manufacturing processes.
• Prepare and review documentation for technology transfer and lifecycle activities.
• Support manufacturing operations during start-up, engineering runs, validation, and routine production.
• Apply engineering principles to problem solving and process support.
• Review batch records, automation recipes, SOPs, and change docs from receiving sites.
• Gather, trend, and analyze process data to support process understanding.
• Lead investigations and deviations, identify root causes, and propose corrective actions.
• Work with cross-functional teams to ensure timely execution of MSAT tasks.
• Identify technical risks and develop mitigation strategies; mentor junior engineers.
• Maintain transfer gap assessments and execution plans; justify risk-based validation approaches.

Connaissances

Technology transfer

Process validation

Root cause analysis

Data trending

Cross-functional collaboration

Engineering judgment

Formation

BS/BA in engineering

MS in engineering

PhD in engineering

Description du poste

Regeneron Pharmaceuticals, Inc. is seeking a Principal MSAT engineer in East Greenbush, NY. You will provide technical leadership for technology transfer, process validation, and ongoing manufacturing support across multiple modalities.

You’ll work with Quality, Regulatory, and Manufacturing to ensure cGMP compliance and robust processes. You will mentor junior engineers, lead defined workstreams, and develop risk-based validation and control strategies.