Fill Finish Process Validation Engineer

Regeneron is currently looking for a Process Controls & Validation Engineer with a focus on drug delivery system assembly, packaging, and labeling manufacturing processes to join our Process Sciences Drug Product Engineering department. This role is responsible for process controls and process validation for labeled drug product (LDP) manufacturing processes. This role will support the Manufacturing and Process Sciences & Drug Product Engineering departments through design transfer, technology transfer, process validation, regulatory filing, and lifecycle management.

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

• Provide technical support for a variety of activities such as design transfer, technology transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities

• Support design transfer and technology transfer activities including approval of manufacturing documentation and procedures, where required.

• Participate in pFMEA for combination product manufacturing processes including assembly, packaging, and labeling

• Generate in-process control procedures and documentation for the combination product assembly, packaging, and labeling manufacturing processes

• Generate validation plan appendices for new manufacturing processes

• Generate and oversee the execution of process validation protocols for process performance qualification and associated studies

• Provide on-the-floor support during protocol execution by manufacturing, as required.

• Present data from validation studies as required.

• Apply statistical process control tools in monitoring the manufacturing process.

• Assist in troubleshooting and continuous improvement activities associated with the manufacturing process.

• Serve as functional area subject matter expert in regulatory inspections.

This role might be for you if you (please add relevant soft skills needed):

• Understand LDP manufacturing processes

• Are knowledgeable of applicable ISO standards and regulations for LDP manufacturing processes

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

• Seek to identify continuous improvement opportunities and can develop new strategies and/or business processes

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Effective time management skills

• Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

To be considered for Process Controls & Validation Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in Engineering; Biomedical Engineering, Chemical Engineering preferred. 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

Experience in biopharmaceutical/combination product development, manufacturing, and/or validation is preferred, but not required.

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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