Sr. Process Controls & Validation Engineer

Regeneron Pharmaceuticals, Inc (USA); New York (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Process Controls & Validation Engineer to lead cGMP validation efforts and develop robust process control strategies from transfer through lifecycle management.

The role requires translating ambiguous problems into actionable plans, collaborating with Manufacturing, Quality, and Regulatory teams, and authoring protocols and regulatory documents with emphasis on ICH guidelines. On-site work in East Greenbush, NY.

Qualifications

• 2+ years of cGMP process validation experience.
• 5+ years for Sr. level, with level determined by experience.
• Experience with process validation, tech transfer and scale up for drug substance.
• BS in Engineering; chemical or biomedical engineering preferred.

Responsibilities

• Leads and provides hands-on support for cGMP process validation (Stage1–3) and lifecycle management.
• Develops and implements process control strategies; supports tech transfer and scale-up.
• Authors protocols, reports, and regulatory documents; supports audits and CMC submissions.
• Collaborates across Manufacturing, Quality, QA, and Regulatory to align lifecycle decisions.

Skills

Process validation experience

Tech transfer experience

Scale-up experience

Cross-functional collaboration

Education

BS 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’re seeking a Process Controls & Validation Engineer with a strong background in cGMP validation, who can develop sound process control strategy, bring structure to ambiguous technical problems, and confidently lead and influence discussions across Manufacturing, Quality and Regulatory teams. 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. This role provides technical support to our bulk manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post‑commercial lifecycle management activities.

When & where: Location: East Greenbush, New York, United States Work Schedule: Monday-Friday, 8am-4:30pm

Discover your role:

• Leads and provides hands‑on support for cGMP process validation (Stage1–3), technology transfer, design transfer, scale‑up, and process control strategy development, from protocol authoring through execution and lifecycle management—translating ambiguous, early‑stage problems into clear, actionable plans with limited direction
• Evaluates product/process risk and applies engineering judgment to resolve gaps and uncertainty as processes move from development to at‑scale manufacturing
• Analyzes data across the process lifecycle—from development through characterization and manufacturing history—using statistics and engineering principles to inform control strategy, validation decisions, and identify critical process parameters, control limits, and monitoring plans
• Leads and influences cross‑functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory, driving alignment and decisions on process lifecycle management, and effectively navigating differing stakeholder priorities
• Authors protocols, reports, and technical documents grounded in available process/product knowledge; ensures SOPs, policies, and validation plans align with industry/regulatory expectations (e.g., ICH); supports audits/inspections and CMC sections of regulatory submissions as needed
• Provides hands‑on support for laboratory and manufacturing‑scale studies, working effectively in a team‑oriented environment

This role requires:

• BS in Engineering; chemical engineering or biomedical engineering preferred
• Process Controls & Validation Engineer: 2+ years of experience
• Sr. Process Controls & Validation Engineer: 5+ years of experience
• Level will be determined based on experience
• Experience with process validation, tech transfer and scale up for drug substance

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.

Salary Range (annually) $67,400.00 - $128,700.00

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.

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award‑winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.