Senior Manufacturing Engineer II

Kindeva Drug Delivery; Lexington (KY); On-site; USD 90,000 - 120,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Sr. Manufacturing Engineer II to enhance manufacturing excellence through process optimization and equipment innovation. The role involves troubleshooting, data analytics, and leading continuous improvement initiatives in a fast-paced environment. Candidates should have extensive experience in the pharmaceutical industry and strong analytical skills. Join us in making a difference in patient health!

Qualifications

• 10+ years of manufacturing experience in the pharmaceutical industry.
• Proven track record of implementing improvement initiatives.

Responsibilities

• Lead efforts to monitor and optimize manufacturing equipment performance.
• Develop and maintain measurement systems for KPIs.
• Assist with manufacturing equipment-related deviations and root cause analysis.

Skills

Analytical Skills

Problem Solving

Communication

Education

Bachelor’s degree in Engineering

Tools

Lean Tools

Smartsheet

Power BI

SQL Development

Job description

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make: As a Sr. Manufacturing Engineer II, you will play a critical role in driving manufacturing excellence through process optimization, equipment innovation, and cross-functional collaboration. By leading initiatives that enhance productivity, quality, and compliance, you will directly contribute to improved operational performance and product reliability. Your ability to develop and implement scalable manufacturing solutions, resolve complex technical challenges, and partner with stakeholders will support continuous improvement and long-term business success. With a hands-on, data-driven approach, your expertise will help shape efficient, cost-effective, and compliant manufacturing processes that align with company goals and customer expectations.

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.

Qualifications:

Basic Qualifications:

• Bachelor’s degree in Engineering or related field and/or equivalent experience
• 10+ years of manufacturing with relevant 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

Preferred Qualifications

• Experience with automation, nasal, or related drug delivery device manufacture and packaging.
• 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

Physical Requirements:

• Specific vison requirements include; close vision, distance vision, color vision, and the ability to adjust and focus in order to read/understand/execute documentation as required by the position
• Employee are required to follow all cGMP and safety procedures.
• The employee must wear all required safety equipment and perform assigned work in a safe manner.
• Employee must use proper lifting techniques and be conscious of hazards around him/her.
• Must follow all GMP and safety procedures within the department.
• The employee must occasionally lift and/or move up to 20 pounds.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

• Job Family B - Engineering - Automation Engineering