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Regeneron is currently looking for a Process Control & Validation Engineer to join our Controls Systems and Strategies team. This position is part of the Process Sciences Drug Product Engineering department. The Process Controls & Validation Engineer provides engineering support for the design and development of robust drug product processes that enable the delivery of life transforming medications to patients globally. The individual will design and refine drug product unit operations from freeze/thaw through filling and inspection and will be part of a team responsible for industrialization, troubleshooting, and validation of drug product processes at manufacturing sites, both international and domestic.

As a Process Controls & Validation Engineer, a typical day might include the following:

• Up to 10% lab exposure.

• Collaborate with cross-functional teams to define and execute drug product process development and technology transfer activities. Provide engineering expertise to cross-functional teams.

• Design, model, and implement scale-up strategies for drug product unit operations with a focus on process characterization, identification of critical process parameters and process optimization.

• Write and review product industrialization protocols and reports to support technology transfer and process validation.

• Support primary component selection and design as well as life-cycle initiatives.

• Support process investigations and assist with product impact assessment for change controls and internal/external investigations.

• Perform at-scale hands-on experiments and in-process testing to support process development and product industrialization.

• Continuously drive to improve processes for improved performance.

This role might be for you if you:

• Are willing and able to travel up to 20%.

• Have strong interpersonal, cross- cultural, communication, negotiation, and problem-solving skills.

• Show resiliency and flexibility in the face of challenges and adversarial situations.

• Are able to provide clear direction to others in ambiguous situations and environments and communicate with transparency and composure.

• Possess knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.)

• Apply technical expertise and may contribute to the development of new concepts, techniques and standards.

• Can set and execute priorities.

To be considered for the Process Controls & Validation Engineer position you must be willing and able to work, Monday-Friday, 8am-4:30pm. You must have a BS in Engineering, chemical engineering, biochemical engineering, or related engineering field. For various levels you must have the following:

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

• Sr. Process Controls & Validation Engineer- 5+ years of relevant experience

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)

$65,100.00 - $124,300.00