CSV Lead

**Job Summary** The CSV Specialist will lead and support Computer System Validation (CSV) activities, specifically for computerized systems used in the development and manufacture plantswithin a pharmaceutical environment. This role requires a deep understanding of CSV regulations, quality standards, and an ability to ensure compliance with both FDA 21 CFR Part 11, EU Annex 11, and other regulatory requirements. 1. **Validation Planning and Execution** - Lead and manage CSV projects for new and existing computerized systems, ensuring adherence to CSV lifecycle processes and compliance with regulatory standards. - Develop and maintain validation documentation, including validation plans, protocols, summary reports, and risk assessments. - Conduct system risk assessments, functional and technical assessments, and determine validation strategy. 2. **Regulatory Compliance* -Ensure compliance with FDA, EU, and global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . **Project Management** - Collaborate cross-functionally with IT, Quality, Manufacturing, and R&D teams to manage and execute validation projects, including system upgrades, migrations, and implementation of new computerized systems. - Develop and maintain project timelines and resource allocation, ensuring timely completion of validation activities. 4. **Documentation and SOP Development** - Author, review, and approve Standard Operating Procedures (SOPs), Work Instructions, and other CSV documentation. - Maintain and update documentation for validation activities, ensuring alignment with Good Documentation Practices (GDP). 5. **Training and Support** - Train and mentor team members on CSV processes, regulatory requirements, and best practices for maintaining validated systems. - Provide technical support during audits and inspections by regulatory authorities and internal quality audits. 6. **Continuous Improvement** - Identify and implement process improvements to enhance efficiency, compliance, and reliability of computerized systems. - Develop risk mitigation strategies and contribute to overall process excellence in CSV practices. ### **Qualifications** - **Education**: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field. Advanced degree preferred. - **Experience**: 10-15 years of relevant experience in CSV within the pharmaceutical and/or medical device industry. - **Technical Skills**: - Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other regulatory standards. - Proficient in validation protocols, testing methodologies, and risk management principles. - Familiarity with IT infrastructure, software development lifecycle (SDLC), and Quality Management Systems (QMS). - **Soft Skills**: Excellent communication and interpersonal skills, with the ability to manage multiple stakeholders and work effectively in cross-functional teams. - **Certifications**: Preferred certifications include Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or equivalent CSV-related certifications. ### **Other Requirements** - Ability to work in a highly regulated environment and under strict quality and regulatory guidelines. - Strong analytical and problem-solving skills, with a focus on compliance and risk-based validation. - Willingness to travel for audits, training, and support, as required.