Principal Engineer (Drug Product MSAT)

We are currently looking to fill a Staff Engineer, Drug Product Manufacturing Science and Technology position. This role will serve as a process specialist in equipment selection/qualification activities, new technology development and implementation, manufacturing network strategy, sophisticated investigation resolution and may be hands on solving issues during technology transfer and cGMP start-up. The 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. The Staff Engineer may also provide floor support during operations at internal/external manufacturing facilities, use sophisticated analytics to review process data to ensure operational consistency.

In this role, a typical day might include the following:
• Serving as a technical specialist for drug/combination product manufacturing processes, new product introduction, technology transfer (to/from CMO, partner, internal sites, etc.), technical process troubleshooting and issue resolution within a GMP environment
• Leading equipment selection, installation and qualification (FAT/SAT/IQ/OQ) of equipment including single-use system mixing, filtration, filling (i.e. vial, pre-filled syringe, etc.), lyophilization, sterilization, device assembly, packaging, etc. Collaborate with Engineering, Manufacturing and Quality to ensure robust procedures are developed/utilized for equipment operation and training
• With the support of multi-functional teams, acting as the technical lead for technology transfer of the processes to manufacturing facilities
• Supervising and reporting project landmarks related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation
• Leading investigations, determining root cause, and identifying/implementing CAPA for manufacturing deviations
• System Administration of process development documentation and tracking systems.
• Development and management of system related overview documents procedures including Process flows, SOPs and work instructions.

This role might be for you if you:
• Enjoy interacting with internal and Contract Manufacturing Organizations
• Have proven technical expertise in drug product manufacturing, product development and validation, lyophilization, visual inspection, sterilization, automation
• Are experienced in aseptic manufacturing and/or drug product technical transfer/technical support
• Are interested in domestic and international travel 10-25% of the time

To be considered for this role you must hold a Bachelor's degree in an Engineering and 8+ years of related experience for the Principal Engineer level, 10+ years for the Staff Engineer level, 12+ years for the Sr Staff Engineer level. Equivalent combination of education and experience considered. Level is determined based on qualifications relevant to the role.

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.
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