Technology Transfer Engineer

Build Our Future Together
At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are looking for a Process Controls & Validation Engineer to join our Process Sciences Drug Product Engineering department. This technical services department handles a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. The role provides technical support to manufacturing, quality, chemistry and regulatory teams for processes from technology transfer and/or design transfer through post‑commercial lifecycle management activities.

When & Where

Location: Rensselaer, New York, United States

Work model: Monday‑Friday, 8 am‑4:30 pm

Travel: ~10% domestic and occasionally international

Discover Your Role

Evaluate product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and post‑commercialization activities

Analyze information and data from development through late‑stage characterization and at‑scale manufacturing history

Author protocols, reports, and other technical documents with conclusions based on all available process and product knowledge

Ensure alignment of SOPs, policies, validation plans and other internal documentation with industry and regulatory expectations such as ICH guidelines

Support audits/inspections and drafting of chemistry manufacturing compliance sections of regulatory submissions as needed

Analyze data using statistics, engineering principles, and other techniques to gain insight into manufacturing process performance and control

Support laboratory studies and at‑scale studies performed to support process characterization and validation activities

This Role Requires

BS in bioengineering, chemical engineering, or a related engineering field

Background in aseptic processing, drug substance development, drug product development, combination product development or biopharmaceutical/combination product validation is preferred

Experience:

Associate Process Controls & Validation Engineer: 0‑2 years

Process Controls & Validation Engineer: 2+ years

Level determined based on experience

Why Join Regeneron
We are an equal‑opportunity employer and provide reasonable accommodations. Salary range: $62,355–$110,000 annually. We offer a comprehensive rewards package and a commitment to an inclusive culture.

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