Process Engineer – Aseptic Fill/Finish

Stark Pharma Solutions Inc; Bradley (IL); On-site; USD 90,000 - 140,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking an experienced Process Engineer to support aseptic fill/finish operations at our Bradley, IL, site.

The role involves designing, implementing, starting up, and optimizing fill/finish equipment and processes to ensure sterile manufacturing readiness. Responsibilities include commissioning new lines, developing recipes, and collaborating with Validation/CQV teams during IQ/OQ/PQ.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5–7+ years in pharmaceutical, biologics, or sterile manufacturing environments.
• Experience with aseptic fill/finish manufacturing processes.
• Hands-on experience with equipment startup, commissioning, and process optimization.
• Familiarity with GMP manufacturing requirements and sterile processing.

Responsibilities

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

Skills

Aseptic processing

Equipment startup

Process optimization

Troubleshooting

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Job description

Process Engineer Aseptic Fill/Finish

Location: Bradley, IL (100% Onsite 5 Days/Week)

Contract Duration: 12+ Months

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.

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.