Senior Manufacturing Engineer I

Germer International; Lexington (KY); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical manufacturing company located in Lexington, Kentucky, is seeking an experienced professional to optimize manufacturing equipment performance, analyze data for continuous improvements, and ensure compliance with regulatory standards. The ideal candidate will possess a Bachelor's degree in Engineering, a strong background in the pharmaceutical sector, and excellent problem-solving and communication skills. Lean manufacturing or Six Sigma certifications are preferred. This role offers a dynamic work environment with multiple project management opportunities.

Qualifications

• 5+ years of relevant manufacturing experience in the pharmaceutical industry.
• Proven ability to implement improvement initiatives successfully.
• Experience with technical writing such as SOPs and user requirement specs.

Responsibilities

• Monitor and optimize manufacturing equipment performance.
• Troubleshoot complex equipment issues.
• Develop measurement systems for key performance indicators.

Skills

Lean manufacturing

Data analysis

Problem-solving

Communication

Education

Bachelor’s degree in Engineering or related field

Master’s degree in relevant field

Tools

Power BI

SQL Development

Automation systems

Job description

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 and ensure optimal operational efficiency.
• 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 key performance indicators (KPIs) in manufacturing.
• 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, and 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:

Basic Qualifications

• Bachelor’s degree in Engineering or related field and/or equivalent experience
• 5+ years of manufacturing of relevant experience in the pharmaceutical industry with a Bachelor’s degree; and 3+ years’ experience in the pharmaceutical industry and a Master’s degree.
• 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
• Other duties as assigned