Regeneron Pharmaceuticals, Inc. is hiring an Associate Fill/Finish Manufacturing Engineer to provide technical support for assembly and packaging processes and manufacturing operations. The role supports equipment design and selection, process development, technology transfer, cGMP start-up, routine manufacturing, validation, and training.
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, 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
May lead others
Qualification
Required
BS in engineering with 0+ years industry experience; MS with 0+ years industry experience
BS in engineering with 2+ years industry experience; MS with 1+ years industry experience
BS in engineering with 5+ years industry experience; MS with 3+ years industry experience
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
Preferred
Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations
Previous experience providing technical support
Experience with operating and qualifying equipment with high levels of automation
Benefits
Depending on country and role, annual bonuses or other incentive plans
Depending on country and role, equity awards
Depending on country and role, pension or retirement benefits
Depending on country and role, 401(k) company match
Depending on country and role, health and wellness programs
Depending on country and role, fitness centers
Depending on country and role, insurance benefits (e.g. medical, dental, vision, life and disability)
Depending on country and role, paid time off
Depending on country and role, family support benefits
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
