Process Engineer

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

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit: www.piramalpharmasolutions.com

Job Title

Process Engineer II

Job Description

The Process Engineer works to design and efficiently transfer new processes into manufacturing, optimize existing processes, ensuring the achievement of quality, yield, and capacity timelines.

Drafts experimental, development, and operational studies to expand expertise in parenteral manufacturing.

• Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations.
• Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time.
• Interfaces with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment.
• Take initiative to develop and improve procedures and setups through the change control process.
• Prepares and reviews technical documents to include but not limited to: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols.
• Contributes to investigations and deviations related to manufacturing, defines root causes and implements corrective actions.
• Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required.

Bachelor of Engineering (Chemical), English