Process Engineer II - Scale-Up & GMP Excellence

MilliporeSigma; Indianapolis (IN); On-site; USD 67,300 - 100,900; Full time

Benefits offered by this job

Health insurance

PTO

retirement contributions

Job summary

MilliporeSigma is seeking a skilled engineer to provide technical oversight for bulk formulation, fill-finish, and high-speed packaging across commercial operations. You will lead scale-up and transfer of new products, ensuring seamless integration into existing lines and equipment.

The role requires 4+ years in pharmaceutical operations with GMP/FDA experience, plus strong skills in process control, documentation, and cross-functional coordination.

Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, Biochemical Engineering or other Life Science or Engineering discipline.
• 4+ years of work experience in pharmaceutical operations.
• 4+ years of work experience in US and European GMP requirements and FDA guidelines.

Responsibilities

• Provide technical engineering oversight for all phases of commercial operations, including bulk formulation, fill-finish, and high-speed packaging.
• Lead the scale-up and transfer of new clinical and commercial products, ensuring seamless integration into existing production lines and equipment.
• Manage multiple concurrent technical projects valued up to $250K, overseeing the full lifecycle from capital appropriation and budgeting to execution and staffing.
• Serve as the primary technical point of contact for internal and external clients, coordinating deliverables across cross-functional departments and contractors.
• Act as a SME to lead process investigations, identify root causes for deviations, and implement continuous improvement initiatives.
• Design and specify equipment for bulk processing and filling systems, including hydraulic, heat transfer, and material balance calculations.
• Author and update critical site documentation, including SOPs, P&IDs, electrical drawings, and validation protocols to ensure regulatory compliance.
• Develop and modify control loops and PLC ladder logic to optimize manufacturing equipment performance and process reliability.

Skills

Process engineering

Project management

GMP compliance

Technical documentation

PLC/Control systems

Education

Bachelor’s degree in Chemistry or related field

4+ years pharmaceutical operations

Tools

AutoCAD

Microsoft Visio

Minitab/JMP

Job description

MilliporeSigma is seeking a skilled engineer to provide technical oversight for bulk formulation, fill-finish, and high-speed packaging across commercial operations. You will lead scale-up and transfer of new products, ensuring seamless integration into existing lines and equipment.

The role requires 4+ years in pharmaceutical operations with GMP/FDA experience, plus strong skills in process control, documentation, and cross-functional coordination.