Senior Manufacturing Engineer II

Job Description

ROLE SUMMARY

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.

This role will assist in the design and procurement of new processes and utility equipment and will be a key SME for installation, start-up, commissioning or qualification activities to ensure that equipment and process are commercially viable.

ROLE RESPONSIBILITIES

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.

Other duties as assigned.

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.
• Proven track record of successfully implementing improvement initiatives in a pharmaceutical manufacturing environment.
• Strong analytical and problem-solving skills with the ability to use data to drive decision-making.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across multiple departments.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Technical writing experience such as: SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal
• Experience with automation, nasal, or related drug delivery device manufacture and packaging.

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 ex.
  • Serialization - Antares, Tracelink
  • Data historian – Aveva OSI PI
  • Reporting Systems – OSI PI, MS Report Builder, SQL Development
  • Kepware, Matrikon, AB Factory Talk
  • Automated Visual Inspection