We are currently looking to fill a Principal Fill/Finish Manufacturing (MFG) Engineer. As a Principal Fill/Finish MFG Engineer, they will serve as an expert for formulation, aseptic filling, visual inspection (manual and automated), 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.

As a Principal Fill/Finish MFG Engineer, a typical day might include the following: 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.

Leads tech transfer / tech transfer studies, investigations, innovative technology adoption and continuous improvement initiatives.

Develops strategy for cycle development and other studies on manufacturing equipment as defined by end user needs.

Stays abreast of latest technologies and industry benchmarks to make recommendations to senior management.

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.

Leads functional evaluation of new components and raw materials for feasibility of use on manufacturing equipment.

Reviews Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.

Supports SOP development and revision for assigned equipment and process operations.

Drives innovation in fill/finish manufacturing equipment and techniques by keeping abreast of latest technological advancements.

Recommends capital expenditures and aids in the realization of capital projects.

May represent manufacturing during regulatory and client audits.

Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently.

Up to 30% travel (domestic and international) may be required (during project phase).

May lead and/or manage others

Partners cross functionally to establish standards for formulation and filling.

Identifies and solves customer problems with minimal supervision

Negotiates with external parties on behalf of IOPS

Coaches others on effective problem solving

Uses technical expertise to influence decision making to a non-technical audience

This role might be for you if: Knowledge of cGMP manufacturing environment and familiarity with formulation, aseptic filling, visual inspection (manual and automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products.

Demonstrated strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.

Exhibits confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness.

Ability to gain understanding from provided instructions and work towards established goals individually or as part of a team.

Ability to understand and listen to team members and stakeholders’ needs while supporting a positive team environment

Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred.

Previous experience providing technical support preferred.

Experience with lyophilization is a plus.

Experience with operating and qualifying equipment with high levels of automation is a plus.

To be considered for the Principal Fill/Finish MFG Engineer you must have a BS/BA in Engineering with 8 years of relevant industry experience or equivalent combination of education and experience.