The Manufacturing Sciences and Technologies (MSAT) Device Assembly and Packaging Engineer will serve as combination device and secondary packaging design and development lead for biologic product packaging (clinical and commercial) within the production network. This role will also serve as a technical representative for CMO selection strategy, equipment qualification activities, and will 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. The position will also focus on ensuring site to site consistency after the processes are successfully transferred, provide floor support during operations of offsite manufacturing, review process data to ensure operational consistency and provide support for investigations.
In this role, a typical day might include the following:
- Drives innovation in the area of device assembly, labeling and packaging by paying attention the latest technological advancements and ensuring a creative environment and implementation along the business case and Regeneron’s needs. This includes 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 and update technical or procedural documents as needed
- Serves as the process professional providing oversite for development artwork and specifications for components used for commercial production of Regeneron and partner products
- Supervise 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
- Executes development of new and revised components for new product introduction or existing product lifecycle management according to the established implementation target. Collaborates to develop the 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 along with the change control process for the artwork and package component specifications associated with new product
- Create data analytics to serve as metrics and to assist in investigations and as feedback to process to achieve the intended process control strategy.
- Travel as required to CMOs or business partners, approximately 25-30 % travel (domestic and international).
- Demonstrated technical expertise in device assembly, package development and packaging production process standard methodology for biologics, combination product and drug delivery devices. Manufacturing or Package engineering and development preferred.
- Graphic Arts development process experience and CAD skills are a plus.
- Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 are a plus.
- Familiarity with package testing standard methodology for biologics, combination products and devices. Experience in process validation (IQ, OQ and PQ) is a plus
- Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
- Strong project management, interpersonal, cross- cultural, communication and problem-solving skills qualification preferable.
- Associate Engineer level - BS in Packaging Engineering, Biomedical Engineering, Mechanical Engineering or related Engineering field, with 0-2 years of related experience.
- Engineer level - BS in Packaging Engineering, Biomedical Engineering, Mechanical Engineering or related Engineering field, with 2+ years of related experience.
- Sr Engineer level - BS in Packaging Engineering, Biomedical Engineering, Mechanical Engineering or related Engineering field, with 5+ years of related experience.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.