Process Engineer II: Scale-Up & GMP Manufacturing

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

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Perquisites

Job summary

MilliporeSigma in the United States invites you to join a team engineering scalable solutions for clinical and commercial products. You will provide technical oversight across bulk formulation, fill-finish, and high-speed packaging, and lead transfer to existing lines.

You will manage multiple projects up to $250K, serve as SME for deviations and CAPA, design equipment, update SOPs and validation protocols, and optimize PLC controls to improve reliability.

Qualifications

• Bachelor's degree in a Life Science or Engineering field.
• 4+ years in pharmaceutical operations.
• 4+ years of GMP/FDA experience.
• Experience with bulk processing, fill-finish and high-speed packaging.

Responsibilities

• Provide technical oversight for bulk formulation, fill-finish (RABS/Isolator), and high-speed packaging.
• Lead scale-up and transfer of new products into production lines.
• Manage multiple projects up to $250K from budgeting to staffing and execution.
• Serve as SME and coordinate deliverables across cross-functional teams and contractors.
• Lead process investigations and implement continuous improvement initiatives.
• Design equipment for bulk processing and perform related calculations.
• Update SOPs, P&IDs, electrical drawings and validation protocols.
• Develop and modify PLC control logic to improve equipment performance.

Skills

Technical leadership

Project management

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Chemistry/Engineering

Master's degree (preferred)

Tools

Microsoft Office

MS Visio

AutoCAD

Kepner-Tregoe

Minitab/JMP

Job description

MilliporeSigma in the United States invites you to join a team engineering scalable solutions for clinical and commercial products. You will provide technical oversight across bulk formulation, fill-finish, and high-speed packaging, and lead transfer to existing lines.

You will manage multiple projects up to $250K, serve as SME for deviations and CAPA, design equipment, update SOPs and validation protocols, and optimize PLC controls to improve reliability.