Assoc Fill/Finish Engineer

About the role

The Fill/Finish MFG Engineer 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.

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.
• Leads 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, 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 others

Requirements

• Associate Engineer: BS in engineering with 0+ years industry experience; MS with 0+ years industry experience or equivalent combination of education and experience.
• Engineer: BS in engineering with 2+ years industry experience; MS with 1+ years industry experience or equivalent combination of education and experience.
• Sr. Engineer: BS in engineering with 5+ years industry experience; MS with 4+ years industry experience or equivalent combination of education and experience.

Qualifications

• 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.
• Experience with serialization and serialization systems is a plus.

Pay

Salary Range (annually) $62,355.00 - $92,400.00