Process Engineer - Aseptic Filling & Formulation Support - 176745

Responsibilities: of the Process Engineer - Aseptic Filling & Formulation Support: • Provide process engineering support for aseptic filling operations within sterile manufacturing environments. • Support startup, commissioning, qualification, and operational readiness activities for filling lines and associated equipment. • Troubleshoot process and equipment performance issues to improve operational efficiency and reliability. • Review, evaluate, and optimize aseptic manufacturing workflows and production processes. • Support investigations, deviations, CAPAs, and change controls related to aseptic processing operations. • Collaborate with Manufacturing, Validation, Automation, and Quality teams to ensure successful project execution. • Participate in technology transfer activities, process scale-up efforts, and manufacturing readiness programs. • Serve as an owner's representative supporting capital projects from design through implementation. • Interface with engineering firms, equipment vendors, and key internal stakeholders. • Develop process documentation, engineering deliverables, and technical reports. Requirements of the Process Engineer - Aseptic Filling & Formulation Support: • Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related technical discipline. • 5+ years of pharmaceutical manufacturing experience within GMP-regulated environments. • Hands-on experience supporting aseptic filling lines within sterile manufacturing operations. • Experience with injectable drug product manufacturing and parenteral manufacturing processes. • Knowledge of sterile formulation, compounding, and aseptic processing technologies. • Experience with vial, syringe, and/or cartridge filling systems. • Familiarity with isolators, Restricted Access Barrier Systems (RABS), and cleanroom operations. • Experience supporting facility expansions, capital projects, commissioning, and qualification activities. • Understanding of process validation, technology transfer, change management, deviations, and CAPA processes. • Ability to function independently while managing multiple priorities and project deliverables. Compensation: for the Process Engineer - Aseptic Filling & Formulation Support: • Salary range: • Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.