Process Validation Engineer (Fill Finish)

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k) match

Health benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls & Validation Engineer in East Greenbush, NY. The role focuses on fill-finish operations, providing technical support from tech transfer to lifecycle management of manufacturing processes.

The position requires a BS/BA in Engineering and 2+ years (senior level 5+ years). Knowledge of aseptic processing and regulatory considerations is preferred; salary is listed and a comprehensive rewards program applies.

Qualifications

• BS/BA in Engineering (Chemical/Biomedical preferred).
• Process controls and validation experience required.
• Knowledge of ICH guidelines and regulatory expectations.

Responsibilities

• Supports tech transfer, process control strategy, validation and post-commercial activities.
• Evaluates product and process risks throughout the lifecycle.
• Analyzes data from development, characterization and scale-up.
• Collaborates with Manufacturing, QC, QA, and CMC Regulatory.
• Authors protocols, reports and technical documents.
• Ensures SOPs and validation plans meet industry standards.
• Supports audits, inspections and regulatory submissions.
• Applies engineering methods to develop process controls and validation.
• Uses statistics to assess manufacturing performance.
• Supports lab and manufacturing-scale studies.

Skills

Process controls

Validation

Data analysis

Regulatory knowledge

Education

BS/BA in Engineering

Tools

Statistical methods

Job description

Build our future together: Regeneron is seeking a Process Controls & Validation Engineer to join our Process Sciences Drug Product Engineering department. 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 non-lab based role focusing on fill finish operations provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer to post-commercial lifecycle management activities.

When & where:

Location: East Greenbush, New York, United States Work model: Monday-Friday, 8am-4:30pm

• Supports technology transfer, process control strategy, validation, and post-commercialization activities
• Evaluates product and process risks throughout the process lifecycle
• Analyzes data from development, characterization, and at-scale manufacturing
• Collaborates with Manufacturing, QC, QA, and CMC Regulatory to support process lifecycle management
• Authors protocols, reports, and technical documents based on process and product knowledge
• Ensures SOPs, policies, and validation plans align with industry and regulatory standards (e.g., ICH guidelines)
• Supports audits, inspections, and CMC regulatory submissions
• Applies engineering principles to develop and execute process controls and validation strategies
• Uses statistical and engineering methods to assess manufacturing process performance
• Supports laboratory and manufacturing-scale studies

The environment and physical rhythms of the role:

Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire.

This role requires:

BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred

Process Controls & Validation Engineer: 2+ years of relevant experience

Sr. Process Controls & Validation Engineer: 5+ years of relevant experience

Level is determined based on qualifications relevant to the role

A background in aseptic processing/ fill finish, technology transfer, drug product process development, or biopharmaceutical process validation is preferred

Salary Range (annually) $62,355.00 - $110,000.00

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
• 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.

Background Checks:

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.

About Regeneron:

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.