Device Assembly & Packaging Engineer - Regeneron Pharmaceuticals, Inc.

Regeneron is currently looking for a Drug Product (DP) MSAT (Manufacturing Sciences and Technology) Engineer for our Device Assembly and Packaging team. This role will serve as combination device and secondary packaging design and development lead for biologic product packaging (clinical and commercial). Serve as a technical representative for CMO selection strategy, equipment qualification activities, and be hands on solving issues during technology transfer and cGMP start up. The MSAT team will strive to establish standard methodologies for technical support of cGMP manufacturing operations.

As a DP MSAT Engineer, a typical day might include the following:

• Drives innovation in the area of device assembly, labelling and packaging by identifying the latest technological advancements and ensuring a creative environment and implementation aligning to business needs.
• Ensuring site to site consistency after the processes are optimally transferred, provide floor support during operations of offsite manufacturing.
• Technology/design transfer activities, author and release technical requirement documents and associated component specifications/drawings.
• Perform impact assessment for the partner or supplier notifications and develop process maps.
• Serves as the process professional providing oversite for development artwork and specifications for components used for commercial production of Regeneron and partner products.
• Lead all aspects of the supplier network to assure alignment of package component production capability with equipment platforms within the Regeneron production network.
• Collaborate internally and externally to develop the regulatory content for product filings and life cycle changes.
• Implements development of new and revised components for new product introduction or existing product lifecycle management.
• Build component structural formats based on human factors outputs and equipment platform capabilities.
• Coordinates commercial artwork development, package component specification development and review and approval of these document types.
• Change control process for the artwork and package component specifications associated with new product.
• Build data analytics to serve as metrics and to assist in investigations.

This role might be for you if:

• Are willing and able to travel as required to CMOs or business partners, approximately 25-30 % travel (domestic and international).
• You can demonstrate technical expertise in device assembly, package development and packaging production process.
• You have experience in the development of regulated medical devices or combination products under Design Control.
• You have knowledge of (21 CFR 820 / ISO 13485) and ISO 14971.
• You are familiar with process validation (IQ, OQ and PQ).
• Are aware of industry practices (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
• You have strong project management, interpersonal, cross- cultural, communication and problem-solving skills.

To be considered for the DP MSAT Engineer you must be willing and able to work Monday-Friday, 8:00am-4:30pm and are willing to travel. You must have a BS in Packaging Engineering, Mechanical Engineering or related Engineering field. For various levels you must have the following:

• DP MSAT Engineer: 2+ years of related experience
• Sr. DP MSAT Engineer: 5+ years of related experience

Level is determined based on qualifications relevant to the specific 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)