Assoc Fill/Finish MFG Engineer

About the role

The Fill/Finish MFG Engineer will serve as an expert for assembly and/or packaging processes as assigned, directly supporting the operations team. They will support equipment design and selection as well as process development activities. They will be hands-on, solving issues during technology transfer, cGMP start-up, and routine manufacturing for Regeneron internal operations. This role will also support validation and training activities for the assigned equipment, processes, and operators.

Responsibilities

• Acts as technical SME for assigned equipment and areas in fill/finish manufacturing facility.
• Interfaces with other departments such as Engineering, Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance and Quality Control.
• Participates in tech transfer / tech transfer studies, investigations, innovative technology adoption and continuous improvement initiatives.
• Designs and executes cycle development and other studies on manufacturing equipment as defined by end user needs.
• Supports equipment / new technology design, install, and qualification.
• Manages change parts and recipe creation for new product introduction.
• Leads material and component selection, design, and approval. Works with internal stakeholders and external vendors to design, source, and implement materials.
• Performs functional evaluation of new components and raw materials for feasibility of use on manufacturing equipment.
• Reviews Standard Operating Procedures, specifications, regulatory filing