The Senior Manufacturing Engineer II will drive optimizing equipment and manufacturing performance, troubleshooting, and continuous improvement initiatives through leading cross-functional teams to analyze and improve process performance, support Quality Systems (deviation and CAPA), support equipment qualification activities and develop/implement cost savings.

BASIC QUALIFICATIONS

• Bachelor’s degree in Engineering or related field and/or equivalent experience
• 8+ years of manufacturing with relevant experience with a Bachelor’s degree; 6+ years and a Master’s degree; or a PhD with 3 years’ experience in the pharmaceutical industry with a focus on equipment and process improvement.

PREFERRED QUALIFICATIONS

• Lean manufacturing or six sigma certifications
• Proficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc.
• Experience with site-level automation systems

Equipment Performance and Troubleshooting
- 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.
Data Analytics and Performance Analysis
- 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 improvement.
Quality System / Equipment Qualification Support
- Assist with manufacturing equipment-related deviations and root cause analysis as the equipment SME.
- 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.