Senior Process Engineer: GMP Scale-Up & Tech Transfer Lead

MilliporeSigma; Indianapolis (IN); On-site; USD 112,000 - 168,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma is seeking a senior process engineer to execute cGMP process development for sterile injectable products. You will lead a team of engineers, support technology transfer, and coordinate projects with internal and external clients.

The role focuses on process engineering, scale-up, and transfer of new chemical processes from development to full-scale manufacturing, including optimization of PEGylated and nanoparticle formulations.

Qualifications

• Bachelor’s or higher in Chemical/Biochemical/Pharmaceutical Engineering or related field.
• 5+ years experience in pharmaceutical operations (validation/process/project engineering).
• Deep knowledge of US/EU GMP requirements and FDA guidelines.
• Experience with aseptic manufacturing, fill/finish, and related process control systems.

Responsibilities

• Provide technical support for manufacturing processes, including investigations and tech transfer.
• Lead a team of 1-5 engineers supporting process engineering and tech transfer.
• Coordinate and manage small to medium scale projects with budgeting and scheduling.
• Interface with external/internal clients and contractors on contract manufacturing opportunities.
• Develop equipment specs, drawings, and process development protocols.
• Create SOPs and update existing ones.
• Perform hydraulic, heat transfer, and material balance calculations.
• Lead process investigations and support clinical/commercial tech transfer.

Skills

GMP knowledge

Project management

Communication

Team leadership

Problem solving

Education

B.S./M.S. in Chemical/Biochemical/Pharmaceutical Engineering or related field

Tools

Microsoft Project

Minitab

Jump

Microsoft Visio

AutoCAD

Job description

MilliporeSigma is seeking a senior process engineer to execute cGMP process development for sterile injectable products. You will lead a team of engineers, support technology transfer, and coordinate projects with internal and external clients.

The role focuses on process engineering, scale-up, and transfer of new chemical processes from development to full-scale manufacturing, including optimization of PEGylated and nanoparticle formulations.