Principal MSAT Engineer

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

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

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

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://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$92,200.00 - $176,000.00