Process Engineer II — Parenteral Manufacturing & Optimization

Piramal Pharma Ltd; Lexington (KY); On-site; USD 85,000 - 110,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY is seeking a Process Engineer II to design, transfer, and optimize parenteral manufacturing processes, ensuring quality, yield, and capacity timelines. You will draft development studies and support process scaling across manufacturing stages.

The role requires a chemical engineering background, knowledge of cGMP and FDA regulations, and strong cross-functional collaboration with Operations, Validation, QA, and Formulation Development to drive continuous

Qualifications

• Bachelor of Engineering (Chemical) degree required.
• Experience with parenteral manufacturing preferred.
• Knowledge of cGMP and FDA regulations and SOPs.

Responsibilities

• Design and transfer new processes into manufacturing.
• Optimize existing processes for quality, yield, and capacity timelines.
• Draft studies to expand expertise in parenteral manufacturing.
• Resolve deviations and drive continuous improvements.
• Interface with Operations, Validation, QA, and Formulation Development.
• Develop and improve procedures through change control.
• Prepare technical documents (MBR, Change Controls, etc.).
• Investigate deviations and troubleshoot manufacturing problems.

Skills

Process engineering

Process transfer

Quality & cGMP

Root cause analysis

Cross-functional collaboration

Education

Bachelor of Engineering (Chemical)

Job description

Piramal Pharma Solutions in Lexington, KY is seeking a Process Engineer II to design, transfer, and optimize parenteral manufacturing processes, ensuring quality, yield, and capacity timelines. You will draft development studies and support process scaling across manufacturing stages.

The role requires a chemical engineering background, knowledge of cGMP and FDA regulations, and strong cross-functional collaboration with Operations, Validation, QA, and Formulation Development to drive continuous