Sr. Manufacturing Engineer II

Formerly Summit Biosciences Inc. | KDD; Lexington (KY); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Sr. Manufacturing Engineer II to enhance manufacturing excellence through process optimization and equipment innovation. The role involves leading initiatives to improve productivity and compliance, utilizing data-driven approaches to shape efficient manufacturing processes. Ideal candidates will have extensive experience in pharmaceutical manufacturing and strong analytical skills, contributing to operational performance and product reliability.

Qualifications

• 10+ years in pharmaceutical manufacturing focused on equipment and process improvement.
• Technical writing experience (SOPs, Maintenance PMs).

Responsibilities

• Lead efforts to monitor and optimize manufacturing equipment performance.
• Develop and maintain measurement systems to visualize manufacturing KPIs.
• Support deviations and root cause analysis as the equipment SME.

Skills

Analytical

Problem-Solving

Communication

Collaboration

Education

Bachelor’s degree in Engineering

Tools

Power BI

Smartsheet

Job description

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Our Work Matters

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. You will lead initiatives to enhance productivity, quality, and compliance, directly contributing to operational performance and product reliability. Your expertise in developing scalable manufacturing solutions, resolving complex technical challenges, and partnering with stakeholders will support continuous improvement and business success. Using a hands-on, data-driven approach, you will help shape efficient, cost-effective, and compliant manufacturing processes aligned with company goals and customer expectations.

Responsibilities:

• Equipment Performance and Troubleshooting: Lead efforts to monitor and optimize manufacturing equipment performance ensuring compliance with CGMP standards. Troubleshoot and resolve complex issues to minimize downtime. Identify and implement continuous improvement opportunities through upgrades, process modifications, or automation. Lead lean manufacturing, Six Sigma projects, and other process optimization initiatives. Assist with new product/equipment design reviews, process development, and staff training. Serve as a technical contact for clients and contract services.

• Data Analytics and Performance Analysis: Develop and maintain measurement systems to visualize manufacturing KPIs. Use data analytics to analyze equipment performance, identify trends, and recommend corrective actions.

• Quality System / Equipment Qualification Support: Support deviations and root cause analysis as the equipment SME. Contribute to CAPA and Change Controls. Support equipment qualification activities including IOPQ. Assist with audits and respond to action items. Provide SME input on equipment qualification to ensure regulatory compliance.

Qualifications:

Basic Qualifications:

• Bachelor’s degree in Engineering or related field, or equivalent experience.
• 10+ years in pharmaceutical manufacturing with a focus on equipment and process improvement.
• Proven success in implementing improvement initiatives.
• Strong analytical, problem-solving, and data-driven decision-making skills.
• Excellent communication and collaboration abilities.
• Ability to manage multiple projects in a fast-paced environment.
• Technical writing experience (SOPs, Maintenance PMs, etc.).

Preferred Qualifications:

• Experience with automation, nasal, or drug delivery device manufacturing.
• Lean or Six Sigma certifications.
• Proficiency with Lean tools and software (e.g., Power BI, Smartsheet).
• Experience with site automation systems (Serialization, Data Historian, Reporting Systems, etc.).
• Other duties as assigned.

Physical Requirements:

• Vision requirements: close, distance, color, focus.
• Follow all cGMP and safety procedures.
• Wear safety equipment and perform work safely.
• Use proper lifting techniques; occasionally lift/move up to 20 pounds.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Engineering and IT
• Industry: Pharmaceutical Manufacturing