Process Validation Engineer (Fill Finish)

Regeneron; United States; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron in East Greenbush, NY seeks a Process Controls & Validation Engineer to provide technical support for fill-finish operations, technology transfer, and lifecycle management from development to post-commercial steps.

The role collaborates with manufacturing, QC, QA, and CMC Regulatory to implement process controls, validation plans, and regulatory submissions, with focus on ICH guidelines and on-site operations.

Qualifications

• BS/BA in Engineering, Chemical Engineering preferred.
• Process Controls & Validation Engineer: 2+ years of relevant experience.
• Sr. Process Controls & Validation Engineer: 5+ years of relevant experience.
• A background in aseptic processing/fill finish or tech transfer is preferred.

Responsibilities

• 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.

Skills

Process Controls

Validation

Data analysis

Cross-functional collaboration

Education

BS/BA in Engineering

Chemical Engineering preferred

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

Discover your role:

• 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

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.

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 qualificatio