Process Engineer II - Scale-Up & GMP Excellence

Millipore Corporation

Indianapolis (IN)

On-site

USD 67,000 - 101,000

Full time

14 days+

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Benefits offered by this job

Health insurance

PTO

Retirement contributions

Bonus potential

Job summary

MilliporeSigma is seeking a qualified engineer to provide technical oversight for bulk formulation, fill-finish, and high-speed packaging. You will lead scale-up and transfer of products into existing lines, manage multiple projects up to $250K, and act as SME for process investigations and continuous improvement.

Responsibilities include equipment design, validation documentation, SOPs, and PLC control development to optimize manufacturing reliability.

Qualifications

Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering or related field.
4+ years of pharmaceutical operations experience.
4+ years of US/EU GMP and FDA guidelines experience.

Responsibilities

Provide technical oversight for bulk formulation, fill-finish, and high-speed packaging.
Lead scale-up and transfer of clinical and commercial products into production lines.
Manage multiple concurrent projects up to $250K from budgeting to staffing.
Serve as SME to lead process investigations and implement improvements.
Design equipment for bulk processing and filling, with calculations.
Authorize and update SOPs, P&IDs, electrical drawings, and validation docs.
Develop control loops and PLC ladder logic to improve performance.