Sr. Process Controls & Validation Engineer

Regeneron Pharmaceuticals, Inc; Town of East Greenbush (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls & Validation Engineer to lead cGMP process validation and technology transfer from development through commercial scale.

The role involves translating early-stage problems into actionable plans and coordinating with Manufacturing, Quality, and Regulatory teams. The candidate will analyze lifecycle data to inform control strategies, set critical parameters, and develop monitoring plans while ensuring compliance with ICH standards.

Qualifications

• Experience with cGMP process validation (Stage 1-3).
• Ability to lead technology transfer and scale-up activities.
• Ability to analyze data across the process lifecycle using statistics and engineering principles.

Responsibilities

• Lead and provide hands-on support for cGMP process validation, technology transfer, design transfer, scale-up, and process control strategy development.
• Evaluate product/process risk and resolve gaps as processes move to manufacturing.
• Author protocols, reports, and validation documents aligned with ICH guidelines.

Skills

Process validation

Tech transfer

cGMP

Data analysis

Education

BS in Engineering

Chemical or Biomedical Engineering preferred

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 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: Rensselaer, New York, United States


• Work Schedule: Monday-Friday, 8am-4:30pm

Discover your role:

• Leads and provides hands‑on support for cGMP process validation (Stage 1-3), 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

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://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

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)

$67,400.00 - $128,700.00