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Regeneron is currently looking for a Process Controls & Validation Engineer for our Process Controls Development and Lifecycle Management Team. This is a non-lab based role. 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. Process Controls and Validation Engineers provide technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

In this role, a typical day might include the following:

• Provide 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.

• Evaluate product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.

• Analyze information and data from development through late stage-characterization as well as at-scale manufacturing history.

• Liaison with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.

• Author at-scale protocols, reports, and/or 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.

• Provide support to audits/inspections and drafting of CMC sections of regulatory submission as needed.

• Work effectively and efficiently in a team-oriented environment.

• Provides support for laboratory studies and/or studies performed at manufacturing scale.

• Apply engineering principles to the development and execution of process controls and validation strategies.

• Analyze data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.

• Apply principles of biology, chemistry and other scientific fields to the development and execution of validation strategies.

• Analyze data using a combination of statistics, scientific principles and other techniques to gain insights into manufacturing process performance and control.

• Develop and monitor health of the business using key performance indicators.

• Develop and improve multi-functional business and manufacturing processes.

• Stays abreast of industry trends and applies external learning to department strategy. May represent department in conferences and consortiums.

• Lead highly multi-functional and complex projects.

• Up to 10% travel maybe required.

This role might be for you if you:

• Understand antibody manufacturing processes. You have in-depth knowledge of liquid chromatography; experience in analytical chemistry, pharmaceutical sciences and protein characterization using a variety of analytical tools for solution-based analyses.

• Enjoy working in a fast-paced environment.

• You are thorough, quality-driven, and well organized.

• You have the dedication to balance multiple projects and prioritize and implement them independently while excelling at keeping all impacted parties well advised.

• Can take on new and sometimes ambiguous challenges, learning quickly.

• Thorough, good interpersonal and effective technical writing and verbal communication skills.

• You enjoy working in a team environment but can also take ownership of complex projects and technical reports.

• Can develop and drive scientific and/or business-related improvement ideas.

• Have a solid understanding of Microsoft Suite (Word, Excel, Powerpoint).

To be considered for Process Controls & Validation Engineer you must have a BS/BA in Engineering. For various levels you must have the following:

• Associate Process Controls & Validation Engineer: 0-2 years of relevant experience

• Process Controls & Validation Engineer: 2+ years of relevant experience

Experience with cell culture or protein purification preferred. Level is determined based on qualifications relevant to the role.

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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)

$58,480.40 - $106,300.00