Process Engineer II: Scale-Up, GMP & Process Improvement

EMD Group; Indianapolis (IN); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma is seeking an experienced Technical Process Engineer to oversee commercial operations across bulk formulation, fill-finish, and high-speed packaging. You will lead scale‑up and transfer activities, ensuring seamless integration with existing lines and equipment.

The role requires a BS in a life science/engineering field and 2+ years of GMP/FDA experience, with preferred MS in Chemical Engineering and proficiency in MS Visio, AutoCAD, and Minitab/JMP.

Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering or related Life Science/Engineering field.
• 2+ years of work experience in pharmaceutical operations.
• 2+ years of work experience with US and European GMP requirements and FDA guidelines.

Responsibilities

• Provide technical engineering oversight for all phases of commercial operations, including bulk formulation, fill-finish (RABS/Isolator), 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 performing 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

GMP compliance

FDA guidelines

Project leadership

Education

BS in Chemistry/Biochem/ChE

MS in Chemical Engineering

Tools

Microsoft Visio

AutoCAD

Minitab/JMP

Kepner-Tregoe

Job description

MilliporeSigma is seeking an experienced Technical Process Engineer to oversee commercial operations across bulk formulation, fill-finish, and high-speed packaging. You will lead scale‑up and transfer activities, ensuring seamless integration with existing lines and equipment.

The role requires a BS in a life science/engineering field and 2+ years of GMP/FDA experience, with preferred MS in Chemical Engineering and proficiency in MS Visio, AutoCAD, and Minitab/JMP.