Senior Bioprocess Engineer for API Transfer

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 66,000 - 172,000; Full time

Job summary

Lilly in Indianapolis is seeking a Process Engineer in the Bioprocess Clinical Trials Manufacturing Facility to support the manufacture of bulk drug substance (API). You will provide engineering support to maintenance and operations, acting as the primary interface between development and operations during technology transfer and as the main contact for equipment troubleshooting and performance issues.

The role emphasizes monitoring equipment performance, driving improvements, ensuring qualified

Qualifications

• Bachelor's degree in engineering (Chemical, Biomedical, or Mechanical preferred).
• 3+ years of experience working in a manufacturing environment supporting GMP operations.

Responsibilities

• Monitor equipment and process performance using defined indicators to proactively identify risks to production and opportunities for optimization.
• Provide engineering and equipment input for technical transfer of new processes from development into the manufacturing area.
• Identify, lead, and implement continuous improvement initiatives related to equipment performance, reliability, and process capability.
• Maintain a comprehensive working knowledge of the manufacturing processes, associated equipment, facilities, computer systems, and operational practices.
• Drive completion of assigned projects by leading multi-disciplinary teams to develop scope, agree to design, and efficiently execute implementation of project goals.
• Serve as the primary resource for safety issues associated with supported processes and equipment.
• Conduct equipment related investigations and lead implementation of associated corrective and preventative actions.
• Ensure equipment remains in a qualified state throughout its lifecycle through appropriate monitoring, maintenance, and documentation.
• Serve as the primary point of contact for the introduction of new consumables or changes to existing consumables.
• Lead or support equipment commissioning and qualification activities for new and existing assets.
• Act as the user representative for capital projects, providing operational and technical input throughout design, construction, and startup.
• Develop and deliver training materials and tools to transfer equipment knowledge and operational practices to operations and maintenance teams.
• Support the development, review, and approval of preventive maintenance procedures and spare part strategies.
• Ensure ongoing compliance with all applicable Health Safety and Environmental (HSE) and Quality requirements.

Skills

Change Management

Deviation Management

Commissioning and Qualification

Routine Data Monitoring

Root Cause Analysis

Pharmaceutical Experience

Industrial Computer Systems

Education

Bachelor's degree in engineering (Chemical, Biomedical, Mechanical)

Tools

UNICORN

DeltaV

OSI PI

Job description

Lilly in Indianapolis is seeking a Process Engineer in the Bioprocess Clinical Trials Manufacturing Facility to support the manufacture of bulk drug substance (API). You will provide engineering support to maintenance and operations, acting as the primary interface between development and operations during technology transfer and as the main contact for equipment troubleshooting and performance issues.

The role emphasizes monitoring equipment performance, driving improvements, ensuring qualified