Pharma Manufacturing Process Engineer – CI & Validation

Piramal Pharma Ltd; Lexington (KY); On-site; USD 70,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY is seeking a Manufacturing Process Engineer to provide real-time process engineering support for manufacturing, including project design, and implementation of new and existing systems, utilities and equipment. You will ensure quality, compliance and OTIF for all products produced at the Lexington facility.

Reporting to the Engineering Manager, you will serve as SME in change control, validation, and continuous improvement, while supporting day-to-day

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering required.
• 3–5 years of pharmaceutical manufacturing/maintenance experience required (parenteral/sterile filling experience preferred).
• Expertise in troubleshooting production equipment/systems.
• Ability to work a 4-shift rotating days-off schedule to support 24-hour operation.
• PC-literate with Word, Excel, PowerPoint competency.
• Experience with maintenance and administration of Windows-based and industrial networks.
• Experience with automated processes and equipment including HMI software.
• Knowledge of cGMPs including FDA, PMDA, and EU regulations and validation requirements.
• Knowledge/experience in cGMP CA/PA, root-cause analysis and risk assessment.

Responsibilities

• Designs and project manages changes, improvements, new systems or equipment.
• Prepares CCRs, Design Specifications, User Requirements Specifications, System Specifications, Design documents, drawings, and validation documents.
• Leads/assists in Continuous Improvement Projects, researching literature, vendors, and proposals.
• Represents Technical SME in teams to specify, install, troubleshoot and maintain systems, equipment, and processes.
• Supports day-to-day production and maintenance activities.
• Provides training support as required.
• Develops/modifies SOPs for processes and equipment.
• Participates in deviation investigations to identify root causes and corrective actions.
• Creates and maintains drawings and sketches.
• Manages Technical Publications Library for manuals, specs and design information.
• Maintains operation of Validated Systems to keep production capability; upgrades manufacturing related systems.
• Acts as first line for enhancements and upgrades of manufacturing systems.

Skills

Troubleshooting

Automation

Cross-functional

PLC experience

cGMP knowledge

Education

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

Tools

Allen-Bradley ControlLogix

Siemens PLCs

Job description

Piramal Pharma Solutions in Lexington, KY is seeking a Manufacturing Process Engineer to provide real-time process engineering support for manufacturing, including project design, and implementation of new and existing systems, utilities and equipment. You will ensure quality, compliance and OTIF for all products produced at the Lexington facility.

Reporting to the Engineering Manager, you will serve as SME in change control, validation, and continuous improvement, while supporting day-to-day