Manufacturing Process Engineer — GMP & 24/7 Ops

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

Job summary

Piramal Pharma Solutions is seeking a Manufacturing Process Engineer in Lexington, KY. You will serve as a subject-matter-expert, delivering project management, system implementation, and process improvements for facilities, utilities, and equipment.

Reporting to the Engineering Manager, you’ll ensure quality, compliance, and OTIF across products. You’ll support 24/7 operations, develop SOPs, and lead deviation investigations with a strong cGMP mindset.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering.
• 3–5 years of pharmaceutical manufacturing/maintenance experience (parenteral/sterile filling preferred).
• Expertise in troubleshooting production equipment/systems and understanding cGMPs (FDA/PMDA/EU).
• Experience with validation protocols and deviation investigations (CA/PA).
• Shift-flexible to support 24-hour operation with a 4-shift rotating schedule.

Responsibilities

• Designs and project manages changes, improvements, new systems and equipment.
• Prepares CCRs, design specs, user requirements specs, and validation documents.
• Leads continuous improvement projects and manages change control processes.
• Acts as SME in teams for installation, troubleshooting and maintenance.
• Supports day-to-day production and maintenance activities; provides training as needed.
• Develops and updates SOPs for processes and equipment.
• Participates in deviation investigations and root-cause analysis.
• Maintains technical drawings and the Publications Library.
• Manages operation and maintenance of validated systems to maintain production capability.

Skills

Troubleshooting

cGMP knowledge

PLC systems

SOP development

Documentation

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 is seeking a Manufacturing Process Engineer in Lexington, KY. You will serve as a subject-matter-expert, delivering project management, system implementation, and process improvements for facilities, utilities, and equipment.

Reporting to the Engineering Manager, you’ll ensure quality, compliance, and OTIF across products. You’ll support 24/7 operations, develop SOPs, and lead deviation investigations with a strong cGMP mindset.