Manufacturing Process Improvement Specialist
23 hours ago
Novozen Healthcare LLC is seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our production team, you will be responsible for improving manufacturing processes, ensuring compliance with regulatory standards, and driving continuous improvement initiatives.
Key Responsibilities:- Process Optimization: Analyze and optimize manufacturing processes to improve efficiency, reduce waste, and enhance product quality.
- Continuous Improvement: Develop and implement process improvements using Lean, Six Sigma, or other continuous improvement methodologies.
- Regulatory Compliance: Support the validation of manufacturing processes, including equipment qualification (IQ/OQ/PQ) and process validation, ensuring compliance with GMP and FDA standards.
- Troubleshooting: Troubleshoot and resolve issues related to production processes, equipment, and systems to minimize downtime and ensure smooth operations.
- Collaboration: Collaborate with production, quality, and engineering teams to develop and maintain standard operating procedures (SOPs) and ensure compliance with regulatory requirements.
- Equipment Selection: Evaluate and select equipment, materials, and process improvements that enhance production efficiency and product consistency.
- Root Cause Analysis: Conduct root cause analysis of production issues and implement corrective and preventive actions (CAPA).
- Production Data Analysis: Monitor and analyze production data to identify trends, variances, and opportunities for improvement.
- Automation and Digital Solutions: Support the implementation of automation technologies and digital solutions to improve manufacturing operations.
- Bachelor's degree in Engineering (Mechanical, Industrial, Chemical, or related field preferred).
- 3-5 years of experience in manufacturing engineering within the pharmaceutical industry.
- Knowledge of GMP, FDA regulations, and pharmaceutical manufacturing processes.
- Experience with process validation, equipment qualification, and troubleshooting in a regulated environment.
- Strong problem-solving skills with experience in root cause analysis and implementing CAPA.
- Proficiency in Lean, Six Sigma, or other process improvement methodologies.
- Excellent communication and interpersonal skills to work effectively in a cross-functional team environment.
- Proficiency in using CAD software and manufacturing-related software systems (e.g., ERP, MES).
- Familiarity with automation and digital manufacturing technologies is a plus.
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