Associate Process Support Engineer

Regeneron Pharmaceuticals, Inc.; City of Troy (NY); On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Process Support Engineer to provide SME-level technical support across manufacturing operations from technology transfer to post-commercialization.

The role emphasizes protocol development, data-driven process insights, and cross-functional collaboration. Responsibilities include writing studies and regulatory-facing documents, ensuring SOP alignment with ICH guidelines, and supporting risk assessments and audits.

Qualifications

• BA/BS in engineering or related field; 0-2+ years industry experience for Assoc Engineer
• BA/BS in engineering or related field; 2+ years industry experience for Engineer
• BA/BS in engineering or related field; 5+ years industry experience for Sr Engineer

Responsibilities

• Provide SME-level technical support on manufacturing processes from technology transfer through post-commercialization activities.
• Author and execute protocols, studies, reports, and technical documents based on process knowledge, data analysis, and statistics.
• Analyze data using statistics and engineering principles to assess process performance and control.
• Ensure SOPs and internal documentation align with industry and regulatory expectations (ICH).
• Support process and quality risk assessments, audits/inspections, and drafting of CMC sections for regulatory submissions as needed.
• Apply statistics and engineering principles to assessments and investigations across production operations, including fluid dynamics, separations, and process automation.
• Liaise across Regeneron departments and with external vendors/CMOs to manage the process lifecycle.
• Contribute to a team-oriented work environment.

Skills

Process engineering

Statistical analysis

Protocol writing

Regulatory compliance

Cross-functional collaboration

Education

BA/BS in engineering

5+ years industry experience

0-2+ years in related field (Assoc Engineer)

2+ years in related field (Engineer)

5+ years in engineering (Sr Engineer)

Job description

Summary: Process Sciences is a technical services department that deals with a range of scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. Process Support Engineers provide technical support through investigation, scientific assessment, and problem-solving analysis to all production operations both internal to IOPS as well as external manufacturing operations.

Essential Duties and Responsibilities

• Provides technical support to a variety of activities as a subject matter expert (SME) on manufacturing processes from technology transfer through post-commercialization activities.
• Authors and execute protocols, studies, reports, and/or other technical documents to provide rationale based on all available process/product knowledge, data analysis, and statistical methods.
• Analyzes data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.
• Ensures alignment of SOPs, Policies, and other internal documentation such as manufacturing documentation with industry and regulatory expectations such as ICH guidelines.
• Provides support to process and quality risk assessments, audits/inspections, and drafting of CMC sections of regulatory submission as needed.
• Applies statistics and engineering principles, in addition to other scientific disciplines to perform assessments, investigations, and problem-solving strategies across production operations and attributes such as the mechanisms of fluid dynamics, separations, and process automation and control.
• Liaises across Regeneron departments as well as with external parties (such as vendors, suppliers, and Contract Manufacturing Organizations (CMO)) to support management of the process lifecycle.
• Works effectively and efficiently in a team-oriented environment.

Education And Experience

• Assoc Engineer: BA/BS in engineering discipline or related field with 0-2+ years industry experience; or equivalent combination of education and experience.
• Engineer: BA/BS in engineering discipline or related field with 2+ years industry experience; or equivalent combination of education and experience.
• Sr Engineer: BA/BS in engineering discipline or related field with 5+ years industry experience; or equivalent combination of education and experience.

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://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

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.

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

Salary Range (annually)

$62,355.00 - $92,400.00