Senior Fill & Finish Manufacturing Engineer

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 140,000 - 170,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Sr Staff Fill/Finish MFG Engineer to act as an expert for formulation, aseptic filling, visual inspection, assembly, and packaging processes.

You will support equipment design, process development, and tech transfer for Regeneron internal operations. The role involves hands-on problem solving during technology transfer, cGMP start-up, and routine manufacturing, with 30% travel.

Qualifications

• BS/BA in Engineering with 12 years of industry experience
• Knowledge of cGMP manufacturing environment
• Experience with formulation, aseptic filling, visual inspection, labeling and packaging

Responsibilities

• Interfaces with Engineering, Validation, DP Process Development, Regulatory, QA and Quality Control.
• Leads tech transfer studies, investigations, and continuous improvement initiatives.
• Develops strategy for cycle development and other studies on manufacturing equipment.
• 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 design, install, and qualification.
• Leads material and component selection with internal stakeholders and external vendors.
• Reviews SOPs and regulatory filings as needed.
• Supports SOP development and revision for assigned equipment and process operations.
• Recommends capital expenditures and aids in capital projects realization.
• May represent manufacturing during regulatory and client audits.
• Tracks and trends relevant technical and business process metrics.
• 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

Skills

Formulation

Aseptic filling

Visual inspection

Packaging & labeling

cGMP knowledge

Education

BS/BA in Engineering

Job description

Regeneron Pharmaceuticals, Inc. seeks a Sr Staff Fill/Finish MFG Engineer to act as an expert for formulation, aseptic filling, visual inspection, assembly, and packaging processes.

You will support equipment design, process development, and tech transfer for Regeneron internal operations. The role involves hands-on problem solving during technology transfer, cGMP start-up, and routine manufacturing, with 30% travel.