The Impact You Will Make:

Transform Lives Through Innovation As a Manufacturing Engineer II, you will be at the forefront of optimizing equipment performance and driving continuous improvement across our pharmaceutical production lines. You will lead troubleshooting efforts, implement lean manufacturing initiatives, and support equipment qualification activities to ensure seamless, compliant operations. Your ability to analyze data, resolve complex issues, and collaborate across teams will directly enhance productivity, quality, and cost efficiency. As a subject matter expert, you'll also play a key role in the design, installation, and commercialization of new equipment, ensuring readiness for GMP-compliant manufacturing and supporting the delivery of life-changing treatments.

Growth Opportunity

Our Lexington facility is experiencing exponential growth, offering exceptional opportunities for professional development and advancement. Join us during this exciting expansion phase and grow your career while contributing to meaningful healthcare solutions.

Responsibilities:

• Monitor and optimize manufacturing equipment performance in alignment with cGMP standards.
• Troubleshoot and resolve complex equipment issues to minimize production downtime.
• Lead lean manufacturing and Six Sigma initiatives to improve process efficiency and product quality.
• Identify and implement procedural or automation improvements for continuous optimization.
• Support new product and equipment design reviews, process development, and staff training.
• Serve as a technical point of contact for clients and contract manufacturing services.
• Develop and maintain systems to visualize and analyze key performance indicators (KPIs).
• Support equipment-related deviations, CAPAs, and Change Controls as the equipment SME.
• Assist with Installation, Operational, and Performance Qualification (IOPQ) activities.
• Ensure equipment and processes meet regulatory requirements and are fit for commercial use. Oversee labeling, artwork changes, and packaging configurations as needed.

Basic Qualifications:

• Bachelor's degree in Engineering or related field and/or equivalent experience
• 2+ years of relevant experience in manufacturing with a focus on equipment and process improvement.
• Proficiency in CAD software, primarily AutoCAD to design and update comprehensive factory and work cell layouts.
• Create, maintain, and update detailed technical documents, including assembly instructions, work instructions (WIs), and standard operating procedures (SOPs).
• Proven track record of successfully implementing improvement initiatives in a 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.

Preferred Qualifications:

• Experience with automation, nasal, or related drug delivery device manufacture and packaging.
• Knowledge of GMP (Good Manufacturing Practices) and regulatory requirements in the pharmaceutical industry.
• Lean manufacturing or six sigma certifications
• Proficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc.

Why Join Us?

This is an opportunity to make a tangible impact on manufacturing excellence, product quality, and patient outcomes. You'll work alongside passionate professionals in a collaborative environment that values innovation, accountability, and continuous improvement.

Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.

# LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

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