Process Engineer – Aseptic Fill Finish Operations

Job Description

A pharmaceutical CDMO is seeking a Process Engineer to support site-wide process improvement initiatives. The ideal candidate will have hands-on experience optimizing fill line and isolator performance, troubleshooting aseptic processes, and implementing improvements in a cGMP manufacturing environment. Experience with EMA and Optima fill lines, automated vial filling equipment, filling operations, and autoclave processes is required. This role supports manufacturing operations, process documentation, and continuous improvement efforts in a fast-paced production setting.

Key Skills

• Process Engineering, Process Improvements, Manufacturing Troubleshooting
• Fill Finish Manufacturing, Filling Operations, Automated Vial Filling Equipment
• Fill Line Optimization, Isolator Performance Optimization, Aseptic Process Troubleshooting
• EMA Fill Lines, Optima Fill Lines, cGMP Manufacturing
• Autoclave Processes, Formulation and Filling Operations
• SOP Development, Revision and Maintenance; Batch Record Development, Revision and Maintenance; Process Documentation Management
• Associated Support Systems for Filling Equipment, Reliability Engineering

Required Qualifications

• Experience optimizing fill line and isolator performance
• Hands-on experience with aseptic process troubleshooting
• Experience working with EMA and Optima fill lines
• Experience with automated vial filling equipment and associated support systems
• Experience in cGMP pharmaceutical manufacturing environments
• Knowledge of filling operations and autoclave processes
• Ability to implement process improvements and resolve manufacturing issues
• Experience supporting SOPs, batch records, and process-related documentation
• Ability to work effectively in a fast-paced manufacturing environment
• Strong hands-on problem-solving skills

Additional Skills

• Experience supporting formulation and filling activities
• Reliability Engineering experience preferred