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Regeneron is currently looking for a Principal Process Controls and Validation Engineer. 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. The Principal Process Controls and Validation Engineer 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 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.

This role might be for you if you:

• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple projects, prioritize them and execute them independently, while excelling at keeping all impacted parties well advised.

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

• Are able to work in a team environment but can also take ownership of large technical reports and projects.

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

• Understand antibody manufacturing processes.

• 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; Chemical Engineering & Biochemical Engineering is preferred. For various levels you must have the following:

• Principal Process Controls & Validation Engineer: 8+ years of relevant experience

• Staff Process Controls & Validation Engineer: 10+ years of relevant experience

Experience in aseptic processing, drug substance development, drug product development or biopharmaceutical/ combination production validation is preferred. Level is determined based on qualifications relevant to the role.

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)

$90,800.00 - $173,400.00