Fill-Finish Process Validation Engineer — Drive Process Excellence

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

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.