Biologics Process Engineer - GMP & CapEx Expert

Elanco; United States; On-site; USD 85,000 - 130,000; Full time

Job summary

Elanco is seeking a Process Engineer to join our Kansas manufacturing site. You will optimize asset performance, lead data-driven improvements, and support capital projects from design through validation. The role requires applying cGMP standards, QA collaboration, and process validation practices.

You'll work on aseptic processing, single-use bioreactors, and MES/SCADA systems while driving continuous improvement to ensure reliable operations and quality at scale.

Qualifications

• Bachelor’s degree in Life Sciences or an engineering field with relevant post‑baccalaureate experience.
• 3 years in pharmaceutical/biotech, regulated environments (cGMP).
• Experience with process validation, PPQ, FMEA, CAPA, and regulatory compliance.

Responsibilities

• Support operation, control, and optimization of manufacturing assets at the Elwood facility.
• Serve as SME for process and equipment performance; contribute to tech transfer and CI.
• Participate in capital projects: design, install, qualification, validation of equipment.
• Troubleshoot on the floor; maintain compliance with cGMP standards.
• Perform data analysis to drive improvements in throughput and robustness.
• Coordinate with Manufacturing, Quality, and Engineering teams to resolve issues.

Skills

Statistical tools

Process data analysis

Troubleshooting

CAPA implementation

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Engineering

Tools

SCADA

MES

Single-Use Bioreactor Systems

Job description

Elanco is seeking a Process Engineer to join our Kansas manufacturing site. You will optimize asset performance, lead data-driven improvements, and support capital projects from design through validation. The role requires applying cGMP standards, QA collaboration, and process validation practices.

You'll work on aseptic processing, single-use bioreactors, and MES/SCADA systems while driving continuous improvement to ensure reliable operations and quality at scale.