Pharma Manufacturing Process Engineer – CI & Validation

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

Job summary

Piramal Pharma Solutions in Lexington, KY seeks a Manufacturing Process Engineer to provide real-time process engineering support for manufacturing operations. You will design, manage, and implement system changes, ensure quality/compliance, and drive OTIF improvements at the Lexington facility.

The role reports to Engineering Manager and requires a Bachelor's in engineering, 3–5 years pharma experience, and knowledge of cGMP regulations.

Qualifications

• Bachelor's degree in Mechanical, Electrical, or Chemical Engineering.
• 3–5 years of pharmaceutical manufacturing/maintenance experience.
• Knowledge of cGMP validation and FDA/PMDA/EU regulations; experience with commissioning and validation protocols.

Responsibilities

• Designs and manages changes, improvements, new systems and/or equipment.
• Prepares Change Control Records (CCRs), Design Specifications, User Requirements Specifications, System Specifications, Design documents, Drawings, and Validation Documents for improvement and validation activities.
• Leads Continuous Improvement Projects, researches literature and vendors, and executes projects following change control.
• Supports day-to-day production and maintenance activities and develops/updates SOPs.

Skills

Troubleshooting

Process engineering

Continuous improvement

Documentation

Regulatory compliance

Team collaboration

Flexible schedule

Data analysis

Education

Bachelor's degree in Mechanical, Electrical, or Chemical Engineering

Tools

Allen-Bradley ControlLogix

Siemens PLCs

HMI software

Industrial networks

Job description

Piramal Pharma Solutions in Lexington, KY seeks a Manufacturing Process Engineer to provide real-time process engineering support for manufacturing operations. You will design, manage, and implement system changes, ensure quality/compliance, and drive OTIF improvements at the Lexington facility.

The role reports to Engineering Manager and requires a Bachelor's in engineering, 3–5 years pharma experience, and knowledge of cGMP regulations.