Process Engineer – Aseptic Fill/Finish

Key Responsibilities

• Support installation, commissioning, and startup of new aseptic fill/finish production lines.
• Develop and optimize equipment recipes, operating parameters, and manufacturing processes.
• Collaborate with Validation and CQV teams during IQ/OQ/PQ activities.
• Drive process improvements to enhance equipment performance, efficiency, and product quality.
• Troubleshoot equipment and process-related issues during startup and commercial operations.
• Assist with process configuration, equipment qualification, and operational readiness activities.
• Train manufacturing and maintenance personnel on new systems and processes.
• Support cross-functional teams to ensure project timelines and compliance requirements are met.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5-7+ years of experience in pharmaceutical, biologics, or sterile manufacturing environments.
• Strong experience with aseptic fill/finish manufacturing processes.
• Hands-on experience with equipment startup, commissioning, and process optimization.
• Experience developing equipment recipes and configuring manufacturing processes.
• Familiarity with sterile processing and GMP manufacturing requirements.
• Strong troubleshooting and problem-solving skills.

Position Overview

We are seeking an experienced Process Engineer to support the expansion of aseptic manufacturing operations through the design, implementation, startup, and optimization of fill/finish equipment and process systems. This role will play a key part in commissioning new production lines, establishing process parameters, and ensuring operational readiness within a sterile manufacturing environment.