Senior Manufacturing Engineer (Lexington)

Our pharmaceutical client is looking for a hands-on Senior Manufacturing Engineer to lead new equipment and process improvement initiatives. You will be at the forefront and expert of designing and procuring new manufacturing equipment. If you thrive wokring in a fast-paced, highly collaborative environments, this role may be the one for you!

RESPONSIBILITIES

• Lead efforts to monitor and optimize the performance of manufacturing equipment ensuring compliance with CGMP standards.
• Troubleshoot and resolve complex issues to minimize production downtime.
• Identify and implement opportunities for continuous improvement through upgrades, process modification, or alternative solutions. Lead in the development and implementation of procedural or automation improvement changes.
• Lead lean manufacturing initiatives, six sigma projects, and other process optimization efforts to improve productivity, quality, and cost efficiency.
• Assist with new product / equipment design reviews, process development and commercialization activities including training and development of manufacturing staff on operation and process.
• Serve as a technical point of contact for client and contract services.
• Develop and maintain measurement systems to visualize manufacturing key performance indicators (KPIs).
• Use data analytics tools and techniques to analyze equipment performance, identify trends, and recommend corrective action and process improvements
• Assist with manufacturing equipment-related deviations and root cause analysis
• Support the development and execution of Corrective and Preventive Actions (CAPA) and Change Controls to address root causes of equipment failures and performance issues.
• Support equipment Installation, Operation, Performance Qualification (IOPQ) activities.
• Experience supporting client and regulatory audits as well as responding to action items.
• Provide SME input on equipment qualification processes, ensuring fit for commercial manufacturing use, compliance with FDA and other regulatory requirements.

QUALIFICATIONS