Manufacturing Process Engineer

Manufacturing Process Engineer

Piramal Pharma Ltd

Business:
Pharma Solutions

Department:
Facilities, Maintenance & Engineering

Location:

Lexington, Kentucky

Reporting to the Engineering Manager, the Manufacturing Process Engineer serves as a subject‑matter expert and provides real‑time process engineering support to the manufacturing process. The position is responsible for design, project management, and implementation of new and existing systems, utilities, and equipment, and ensures Quality, Compliance, and improved OTIF for all products produced at the Lexington, Kentucky manufacturing facility.

This position reports to the Engineering Manager.

• Designs and project 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, planned and corrective maintenance, and system or process improvements.
• Leads/assists in Continuous Improvement Projects, including identification of opportunities, researching literature and vendors, preparing and presenting proposals, developing and executing projects, and closing projects, all following appropriate change control methodologies.
• Represents Technical Subject Matter Expert (SME) in teams assembled to specify, install, troubleshoot, and maintain systems, equipment, and processes.
• Supports day‑to‑day production and maintenance activities.
• Provides training support as required.
• Develops and or modifies SOPs for the Processes and Equipment.
• Participates in deviation investigations to identify root causes and define corrective and preventive actions (CA/PA).
• Creates and maintains drawings and sketches.
• Manages Technical Publications Library to ensure the relevant manuals, specifications, and design information for all facilities, utilities, equipment, and products are on hand.
• Primary/First Line responsibility for operation and maintenance of the Validated Systems to maintain required production capability.
• Primary/First Line responsibility for enhancements and upgrades of manufacturing related systems to maintain production capability.

• Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering.
• Minimum 3‑5 years of pharmaceutical manufacturing/maintenance experience required (parenteral/sterile filling experience preferred).
• Expertise in troubleshooting production equipment/systems.
• Ability to work a flexible schedule to support 24‑hour operation (requires assignment on a shift for 4‑shift rotating days off schedule).
• PC literate with standard office applications (Word, Excel, PowerPoint) competency.
• Experience with maintenance and administration of both Windows‑based and industrial (e.g., PLC) computer networks.
• Experience with Allen‑Bradley Control Logix and Siemens PLCs; experience with HMI software applications; experience with automating processes and equipment.
• Knowledge and understanding of cGMPs including FDA, PMDA, and EU regulations; knowledge of cGMP validation requirements and techniques; experience with commissioning and validation protocol development and execution.
• Knowledge and experience in cGMP CA/PA, root‑cause analysis, risk assessment, and investigation tools and techniques.

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values‑driven practices.

Piramal Group is proud to be an Equal Employment Opportunity and affirmative action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other legally protected characteristics.

We base our employment decisions on merit, considering qualifications, skills, performance, and achievements. We…