Biologics Process Engineer: mAb Manufacturing Excellence

Elanco; Elwood (IN); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Elanco is seeking a manufacturing engineer to support and optimize operations at the Elwood (KS) monoclonal antibody facility. You will act as a technical expert for process and equipment, contribute to development, data analysis, and technology transfer, and participate in capital projects from design through validation.

The role requires a life sciences or engineering degree with 3+ years in pharma/biotech, cGMP knowledge, aseptic processing, and experience with validation, CAPA, and

Competenze

• Bachelor's degree required in a life sciences or engineering field with 3+ years in related roles.
• Experience in pharma/biotech with regulatory environment exposure.
• Familiarity with cGMP, aseptic processing, and validation activities.

Mansioni

• Support operation, control, and optimization of manufacturing assets and processes at the Elwood facility.
• Serve as SME for process and equipment performance; aid development, data analysis, troubleshooting, tech transfer, and improvements.
• Contribute to capital projects with equipment design, installation, commissioning, qualification, and validation.
• Provide technical solutions for process/equipment challenges and troubleshoot manufacturing on the floor.
• Ensure processes/equipment operate in a compliant, validated state per cGMP and regulatory expectations.
• Assist investigations, root-cause analysis, and CAPA implementation.
• Use data analytics to monitor performance, identify variability, and drive improvements.
• Support full lifecycle of capital projects from design to validation of equipment and systems.
• Document changes through change control; maintain process flows and validation protocols.
• Collaborate cross-functionally with Manufacturing, Quality, and Engineering to resolve issues.

Conoscenze

Pharma industry

cGMP knowledge

Aseptic processing

Process Validation

FMEA risk assessment

PPQ

Regulatory compliance

Statistical tools

Bioreactor SCADA MES

Formazione

Bachelor’s degree in Life Sciences, Electrical Engineering, Industrial Engineering, Mechanical Engineering, or related field

Descrizione del lavoro

Elanco is seeking a manufacturing engineer to support and optimize operations at the Elwood (KS) monoclonal antibody facility. You will act as a technical expert for process and equipment, contribute to development, data analysis, and technology transfer, and participate in capital projects from design through validation.

The role requires a life sciences or engineering degree with 3+ years in pharma/biotech, cGMP knowledge, aseptic processing, and experience with validation, CAPA, and