Principal MSAT Engineer

Regeneron Pharmaceuticals • Valley, AL

3d • $92,200 - $176,000 • Onsite

About The Position

Regeneron is seeking a Principal MSAT Engineer to provide technical support for internal and external manufacturing operations across multiple modalities, with a focus on drug substance manufacturing processes using synthetic chemistry, mainly peptides. The role supports technology transfer, process validation, and ongoing manufacturing activities to ensure processes are implemented, operated, and maintained in compliance with applicable requirements.

The position is based in East Greenbush, New York, with a Monday–Friday schedule from 8:00 a.m. to 4:30 p.m. Travel is 10–50% domestically and sometimes internationally. The role includes leading defined workstreams, maintaining transfer gap assessments and execution plans for sophisticated processes or programs, defining risk-based approaches, and mentoring junior engineers.

Requirements

• Bachelor’s degree in an engineering-related field, with proven experience, or an equivalent combination of education and experience.
• For Principal Engineer: bachelor’s degree in engineering and 8+ years of proven experience; master’s degree and 7+ years; or Ph.D. and 2 years of experience.

Nice To Haves

• Bachelor’s degree in Chemical Engineering or Biochemical Engineering.
• Knowledge of biopharmaceutical manufacturing processes and technology transfer principles.
• Familiarity with cGMP requirements, data-integrity principles, and regulated documentation practices.

Responsibilities

• Provide technical expertise for internal and external technology transfer of drug substance manufacturing processes, mainly involving synthetic chemistry and peptides.
• Generate, review, and support technology transfer and lifecycle documentation, including process descriptions, master plans, reports, and technical documents.
• Provide technical support to manufacturing during start-up, engineering runs, validation, and routine manufacturing.
• Apply engineering principles to problem-solving and process support.
• Review receiving-site manufacturing documentation, including batch records, automation recipes, SOPs, and change documentation.
• Gather, trend, and analyze process data to support process understanding and ongoing performance monitoring.
• Participate in investigations and deviation assessments, and support root-cause identification and corrective actions.
• Work with cross-functional teams, including Manufacturing, Quality, Regulatory, Analytical Sciences, and Engineering, to support timely execution of MSAT tasks.
• Ensure activities align with cGMP standards, data-integrity expectations, and applicable safety standards.
• Identify technical risks and raise issues with proposed mitigation strategies.
• Lead defined workstreams for technology transfers or process validation, coordinating cross-functional inputs.
• Provide technical mentorship to junior engineers.
• Own and maintain detailed transfer gap assessments and execution plans for sophisticated processes or programs.
• Define and justify risk-based approaches for process validation, control strategies, and change implementation.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal