Senior Manufacturing Engineering II

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 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, 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
• 8+ years of manufacturing of relevant experience in the pharmaceutical industry with a Bachelor’s degree; and 6+ years’ experience in the pharmaceutical industry and a Master’s degree or a PhD with 3 years in the pharmaceutical industry and 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
• 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

Physical Requirements:

• Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus to read/understand/execute documentation as required by the position
• Employees are required to follow all cGMP and safety procedures.
• The employee must wear all required safety equipment and safely perform assigned work.
• 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.

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