Job Description
CSV Engineer required to join MES team. The ideal candidate will have extensive experience in managing testing and test schedules, as well as in documentation review and test report generation. This role is critical in ensuring that our systems and processes meet the highest standards of quality and compliance. Initially a 12 month contract. Key Responsibilities: Manage Testing and Test Schedules:Oversee the planning, execution, and monitoring of testing activities to ensure timely and accurate completion. Coordinate with various departments to align testing schedules with project timelines. Documentation Review:Conduct thorough reviews of validation documentation, including protocols, test plans, and test scripts, to ensure accuracy, completeness, and compliance with regulatory standards. Test Report Generation:Compile and analyze test data to generate comprehensive test reports. Ensure that all test results are documented accurately and that any deviations are addressed promptly. Compliance and Quality Assurance:Ensure that all validation activities comply with industry standards and regulatory requirements. Participate in quality audits and implement corrective actions as needed. Collaboration:Work closely with cross-functional teams, including MES IT team, Business MES Team, quality assurance, and Automation, to ensure seamless integration of validation activities into overall project plans. Qualifications: Bachelor's degree in Engineering, Science, or a related field. Proven experience in validation engineering, with a focus on managing testing and test schedules. Strong background in documentation review and test report generation. Excellent analytical and problem-solving skills. Attention to detail and a commitment to quality. Ability to work effectively in a team environment and communicate clearly with stakeholders at all levels. Preferred Skills: Experience in the pharmaceutical or biotechnology industry. Knowledge of regulatory requirements and industry standards (e.g., GMP, ISO). Proficiency in statistical analysis software and validation tools. Skills: Validation Documentation Review Testing and Test Schedules