Process Controls & Validation Engineer - Tech Transfer

Regulatory Jobs; City of Rensselaer (NY); On-site; USD 62,000 - 92,000; Full time

Benefits offered by this job

Annual bonus eligibility

Equity awards

401(k) match

Health benefits

Paid time off

Job summary

Regeneron is seeking a Process Controls and Validation Engineer to provide technical support for manufacturing processes from technology transfer through post-commercial lifecycle management. The role interfaces with Manufacturing, Quality Control and CMC regulatory to ensure robust process control strategies and compliant validation plans.

The ideal candidate will have a background in engineering with increasing levels of responsibility, experience in aseptic processing or biopharmaceutical

Qualifications

• Assoc Engineer: BS/BA in Engineering with 0-2+ years industry experience.
• Engineer: BS/BA in Engineering with 2+ years industry experience.
• Sr Engineer: BS/BA in Engineering with 5+ years industry experience.

Responsibilities

• Provides technical support to technology transfer, design transfer, process control strategy development, and validation lifecycle.
• Evaluates product and process risks during transfer and development activities.
• Analyzes data from development through late-stage characterization and scale-up history.
• Liaises with Manufacturing, Quality Control, QA and CMC regulatory to manage process lifecycle.

Skills

Process controls

Validation

Regulatory liaison

Data analysis

Team collaboration

Education

Assoc Engineer

Engineer

Sr Engineer

Job description

Regeneron is seeking a Process Controls and Validation Engineer to provide technical support for manufacturing processes from technology transfer through post-commercial lifecycle management. The role interfaces with Manufacturing, Quality Control and CMC regulatory to ensure robust process control strategies and compliant validation plans.

The ideal candidate will have a background in engineering with increasing levels of responsibility, experience in aseptic processing or biopharmaceutical