Process Engineer II: GMP Scale-Up & Process Optimization

Millipore Corporation; Indianapolis (IN); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perquisites

Job summary

MilliporeSigma in the United States is seeking a Senior Process Engineer to oversee commercial operations including bulk formulation, fill-finish, and high-speed packaging. You will lead scale-up and transfer of new products, ensuring seamless integration with existing lines and equipment.

The role requires 4+ years of pharma operations experience and familiarity with US/EU GMP and FDA guidelines. Strong skills in AutoCAD, Visio, and data analysis are preferred.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, Biochemical Engineering or related Life Science/Engineering field.
• 4+ years of pharmaceutical operations experience.
• 4+ years of experience with US and European GMP and FDA guidelines.

Responsibilities

• Provide technical engineering oversight for bulk formulation, fill-finish, and high-speed packaging across commercial operations.
• Lead scale-up and transfer of new products into existing production lines and equipment.
• Manage multiple projects up to $250K from budgeting to staffing.
• Serve as primary SME to lead investigations and drive continuous improvement.

Skills

GMP compliance

Process engineering

Automation & controls

Education

Bachelor's degree in Chemistry or Chemical Engineering

Tools

AutoCAD

Microsoft Visio

Minitab

JMP

Job description

MilliporeSigma in the United States is seeking a Senior Process Engineer to oversee commercial operations including bulk formulation, fill-finish, and high-speed packaging. You will lead scale-up and transfer of new products, ensuring seamless integration with existing lines and equipment.

The role requires 4+ years of pharma operations experience and familiarity with US/EU GMP and FDA guidelines. Strong skills in AutoCAD, Visio, and data analysis are preferred.