JobsUSAPrincipal Process Controls & Validation Engineer
Company : BioSpace, Inc.
Location : East Greenbush, NY, 12061
Posted Date : 15 September 2025
Job Type : Other
Category : Mechanical Engineering
Occupation : Validation Engineer
Job Details
Regeneron is currently looking for a Principal/ Staff Process Controls & Validation Engineer for the Labeled Drug Product fill/finish manufacturing processes. This is Monday-Friday, 8am-4:30pm schedule. 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 role provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.
As a Principal/Staff Process Controls & Validation Engineer, a typical day might include the following:
- Provides technical support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
- Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
- Analyzes information and data from development through late stage-characterization as well as at-scale manufacturing history.
- Liaises with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.
- Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge.
- Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
- Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed.
- Applies engineering principles to the development and execution of process controls and validation strategies.
- Analyzes data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.
- Develops and monitors health of the business using key performance indicators.
- Develops and improves cross-functional business and manufacturing processes.
- Works effectively and efficiently in a team-oriented environment.
- Provides support to laboratory studies and/or studies performed at manufacturing scale.
- Can perform advanced problem solving including addressing ambiguous issues and situations.
- Can accurately scope projects - break down work into process steps, develop schedules and tasks, identify, interpret, and communicate risk (process management, measuring & managing work).
- Can deal with changing priorities and are able to adapt to change.
- Can use technical expertise to influence a non-technical audience on a path forward.
- Principal Process Controls & Validation Engineer: 8+ years in Drug Product/Labeled Drug Product
- Staff Process Controls & Validation Engineer 10+ years in Drug Product/Labeled Drug Product
- Or equivalent combination of education& experience in Drug Product/Labeled Drug Product
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$90,800.00 - $173,400.00
Company
Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most 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, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Stock Symbol: REGN
Stock Exchange: NASDAQ
Company info
Website Phone Location Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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