Principal MSAT Engineer

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

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal MSAT engineer to provide support for internal and/or external manufacturing operations across multiple modalities. This individual will support technology transfer, process validation, and ongoing manufacturing support activities to ensure processes are implemented, operated, and maintained in line with compliance.

When & where:

• Location: East Greenbush, NY
• Shift: Monday- Friday- 8-4:30pm
• Travel: 10-50% domestic, sometimes international

Discover your role:

This role will provide key technical expertise for internal and external technology transfer of drug substance manufacturing processes for products utilizing synthetic chemistry, mainly peptides

• Generate, review, and support documentation associated with technology transfer and lifecycle activities, including process descriptions, master plans, reports, and technical documents
• Provide technical support to manufacturing operations during start-up, engineering runs, validation, and routine manufacturing
• Leverage engineering principles during problem solving and process support
• Review manufacturing documentation generated by receiving sites, including batch records, automation recipes, SOPs, and change documentation
• Gather, trend, and analyze process data to support process understanding and ongoing process performance monitoring
• Participate in investigations and deviation of assessments and support identification of root causes and corrective actions
• Work effectively in multi-functional teams (e.g., Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering) to support timely execution of MSAT tasks
• Ensure activities align with cGMP standards, data integrity expectations, and applicable safety standards
• Identify potential technical risks and raise issues with proposed mitigation strategies
• Lead defined workstreams for technology transfers or process validation activities, including coordination of 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

Required Qualifications:

• BS/BA degree in an Engineering related field, with proven experience or equivalent combination of education and experience
• Principal Engineer: BS/BA in engineering field with 8+ years of proven experience ; MS with 7+ years ; or PhD with 2 years of experience
• Staff Engineer: BS/BA with 10+ years of experience and demonstrated cross-site scientific leadership; MS with 9+ years; PhD with 5+ years of experience; or equivalent combination of education and experience
• The level of this position will be determined based on your experience and qualifications.

Preferred Qualifications:

• BS 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

Does this sound like you?

We are committed to building a workplace with an inclusive culture.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://