Senior Aseptic Filling Process Engineer

Takeda Pharmaceutical Co.; United States; On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda is seeking a Process Engineer to support aseptic filling operations and cross-functional improvement activities in partnership with Manufacturing, Quality, Validation, Reliability Engineering, and Supply Chain.

You will provide technical leadership on filling technologies, capital projects, change control, CAPA, troubleshooting, and yield-improvement initiatives to drive higher quality and efficiency.

Qualifications

• Bachelor’s or advanced degree in science or engineering.
• 3+ years of related experience in process engineering or filling operations.
• Strong interpersonal and teamwork skills; ability to lead cross-functional teams.
• Ability to present technical and project-management overviews to senior management.

Responsibilities

• Identify and implement projects that improve quality and efficiency of filling operations.
• Act as technical leader across Quality, Manufacturing, suppliers, and relationship-management activities.
• Lead technical aspects of change requests, non-conformances, CAPA, and improvement programs.
• Lead troubleshooting of component and equipment issues to reduce downtime and resolve complaints.
• Introduce new filling equipment, components, and technologies.
• Author and execute user requirements, technical protocols, and validation protocols.
• Support Manufacturing and Maintenance teams with troubleshooting and training.
• Lead yield-improvement initiatives related to solution loss, overfill, and defects.
• Provide leadership for capital projects from identification to reporting.
• Develop and share technical knowledge related to filling operations and exceptions.

Skills

Project leadership

Interpersonal skills

Communication

Troubleshooting

Education

Bachelor's degree in science/engineering

Tools

Microsoft Project

AutoCAD

SolidWorks

Job description

Takeda is seeking a Process Engineer to support aseptic filling operations and cross-functional improvement activities in partnership with Manufacturing, Quality, Validation, Reliability Engineering, and Supply Chain.

You will provide technical leadership on filling technologies, capital projects, change control, CAPA, troubleshooting, and yield-improvement initiatives to drive higher quality and efficiency.