Job Title : Manufacturing Engineer
Position Summary :
We are seeking a Manufacturing Engineer with 3-5 years of experience in the pharmaceutical industry. The ideal candidate will be responsible for improving manufacturing processes, ensuring compliance with regulatory standards, and driving continuous improvement initiatives.
This role involves collaborating with cross-functional teams to enhance production efficiency, optimize equipment and systems, and ensure product quality.
The Manufacturing Engineer will also be involved in troubleshooting, process validation, and implementing new technologies.
Key Responsibilities :
- Analyze and optimize manufacturing processes to improve efficiency, reduce waste, and enhance product quality.
- Develop and implement process improvements using Lean, Six Sigma, or other continuous improvement methodologies.
- Support the validation of manufacturing processes, including equipment qualification (IQ / OQ / PQ) and process validation, ensuring compliance with GMP and FDA standards.
- Troubleshoot and resolve issues related to production processes, equipment, and systems to minimize downtime and ensure smooth operations.
- Collaborate with production, quality, and engineering teams to develop and maintain standard operating procedures (SOPs) and ensure compliance with regulatory requirements.
- Assist in the design and implementation of new manufacturing systems or modifications to existing systems.
- Evaluate and select equipment, materials, and process improvements that enhance production efficiency and product consistency.
- Conduct root cause analysis of production issues and implement corrective and preventive actions (CAPA).
- Monitor and analyze production data to identify trends, variances, and opportunities for improvement.
- Support the implementation of automation technologies and digital solutions to improve manufacturing operations.
- Ensure compliance with safety, environmental, and regulatory guidelines throughout the manufacturing process.
Qualifications :
- 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.
- Strong organizational and project management skills.
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