Manufacturing Process Engineer

Business:
Pharma Solutions
Department:
Facilities, Maintenance & Engineering

Location:

Lexington

Reporting to the Engineering Manager, the Manufacturing Process Engineer serves as subject-matter-expert and provides real‑time, process engineering support to the manufacturing process. This 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 manufacturing facility in Lexington, Kentucky.

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, researches literature and vendors, prepares and presents proposals, develops and executes projects, and closes 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, design information for all of our facilities, utilities, equipment and products are on hand.
• Primary/First Line responsibility for operation and maintenance of the Validated Systems to maintain production capability required.
• 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 flexible schedule to support 24‑hour operation (requires assignment on shift for 4 shift rotating days off schedule).
• PC literate with standard office application (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.