Sr. Manufacturing Engineer II

ZipRecruiter; Lexington (KY); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Sr. Manufacturing Engineer II to drive manufacturing excellence through process optimization and equipment innovation. The role involves leading initiatives to enhance productivity and compliance, while collaborating with cross-functional teams to ensure operational performance and product reliability.

Qualifications

• 10+ years of manufacturing experience in the pharmaceutical industry.
• Proven track record of implementing improvement initiatives.
• Technical writing experience such as SOPs and user requirement specs.

Responsibilities

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

Skills

Analytical skills

Problem-solving

Communication

Interpersonal skills

Education

Bachelor’s degree in Engineering

Tools

Lean tools

Power BI

Power Apps

Job description

Job Description

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. 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 modifications, 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 clients 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 actions and process improvements.

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, and 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 experience, with relevant focus on equipment and process improvement in the pharmaceutical industry.
• Proven track record of successfully implementing improvement initiatives in pharmaceutical manufacturing environments.
• Strong analytical and problem-solving skills, with the ability to use data to drive decisions.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate across 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 RFPs.

Additional Qualifications:

• Experience with automation, nasal, or related drug delivery device manufacturing and packaging.
• Lean manufacturing or Six Sigma certifications.
• Proficiency with Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc.
• Experience with site-level automation systems, e.g., serialization (Antares, Tracelink), data historians (Aveva OSI PI), reporting systems (OSI PI, MS Report Builder, SQL), Kepware, Matrikon, AB Factory Talk, and automated visual inspection.
• Other duties as assigned.

Physical Requirements:

• Specific vision requirements include close vision, distance vision, and the ability to read, understand, and execute documentation as required.
• Must follow all cGMP and safety procedures, wear required safety equipment, and perform work safely.
• Use proper lifting techniques and be aware of hazards.
• Occasionally lift and/or move up to 20 pounds.

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