Pharma Manufacturing Process Engineer – CI & GMP

Piramal Pharma Limited; Lexington (KY); On-site; GBP 52,000 - 81,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY is seeking a Manufacturing Process Engineer to provide real-time process engineering support, and to design, manage projects, and implement new and existing systems, utilities and equipment.

The role ensures Quality, Compliance, and OTIF across the Lexington facility. You will develop SOPs, participate in deviation investigations, and support training and maintenance activities while collaborating with Engineering leadership.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering is required.
• Minimum 3-5 years of pharmaceutical manufacturing/maintenance experience.
• Experience with PLCs (Allen-Bradley/Siemens) and HMI software.
• Knowledge of cGMPs, validation, and change control processes.
• Ability to support 24-hour operation with a rotating shift.

Responsibilities

• Designs and project manages changes, improvements, new systems and/or equipment.
• Prepares Change Control Records, design specs, URS, DS, and validation documents.
• Leads continuous improvement projects and evaluates vendors and literature.
• Acts as SME in teams to specify, install, troubleshoot and maintain systems and equipment.
• Supports day-to-day production and maintenance activities and trainings.
• Develops or updates SOPs for processes and equipment.
• Participates in deviation investigations and root-cause analysis.
• Maintains drawings, sketches, and Technical Publications Library.
• Oversees operation and maintenance of validated systems to sustain production capability.

Skills

Process engineering

Troubleshooting

PLC/HMI controls

cGMP knowledge

Change control

Documentation

Office software

Education

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

Tools

Windows-based networks

Industrial PLC networks

Allen-Bradley ControlLogix

Siemens PLCs

HMI software

Job description

Piramal Pharma Solutions in Lexington, KY is seeking a Manufacturing Process Engineer to provide real-time process engineering support, and to design, manage projects, and implement new and existing systems, utilities and equipment.

The role ensures Quality, Compliance, and OTIF across the Lexington facility. You will develop SOPs, participate in deviation investigations, and support training and maintenance activities while collaborating with Engineering leadership.