What are the responsibilities and job description for the Cleaning Validation Engineer - 171296 position at Medix?
Position Summary :
We are seeking a highly motivated and detail-oriented Cleaning Validation Engineer to join our pharmaceutical manufacturing team. This role is critical to ensuring that cleaning processes comply with regulatory standards and meet strict quality requirements. The Cleaning Validation Engineer will be responsible for developing, executing, and documenting cleaning validation protocols and ensuring the cleanliness of manufacturing equipment and facilities.
Key Responsibilities :
Cleaning Validation Development :
Develop and implement cleaning validation strategies, protocols (IQ / OQ / PQ), and procedures in compliance with cGMP, FDA, and other regulatory requirements.
Perform risk assessments and determine acceptance criteria for cleaning processes based on product-specific data.
Protocol Execution and Testing :
Conduct cleaning validation studies, including swab sampling, rinse sampling, and residue analysis.
Ensure timely execution of validation activities, including scheduling, monitoring, and reporting.
Data Analysis and Reporting :
Analyze cleaning validation data to confirm effectiveness and reproducibility of cleaning procedures.
Prepare detailed validation reports, including results, conclusions, and recommendations for process improvements.
Compliance and Quality Assurance :
Maintain up-to-date knowledge of regulatory requirements and industry standards for cleaning validation.
Support internal and external audits, providing validation documentation and addressing findings.
Cross-Functional Collaboration :
Collaborate with manufacturing, quality assurance, engineering, and R&D teams to optimize cleaning processes.
Provide training and guidance to operations staff on cleaning procedures and validation requirements.
Continuous Improvement :
Identify opportunities for improving cleaning processes to enhance efficiency, reduce costs, and maintain compliance.
Assist in the evaluation and implementation of new cleaning technologies or equipment.
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