Senior Staff Engineer Validation

A Validation Engineer is responsible for planning, executing, and documenting validation activities to ensure that processes, systems, and products meet specified requirements and comply with regulatory standards. This role involves collaboration with cross-functional teams, adherence to quality protocols, and maintaining compliance with industry regulations. Key Responsibilities : Validation Planning : Develop and implement validation master plans, protocols, and procedures. Define validation strategies based on project requirements and regulatory guidelines. Protocol Development : Create, review, and approve validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Ensure that validation protocols are aligned with industry standards and regulatory requirements. Execution of Validation Activities : Conduct validation testing according to approved protocols. Collaborate with cross-functional teams to execute validation activities, including equipment, process, and cleaning validation. Investigate and troubleshoot any deviations or issues encountered during validation. Data Analysis and Documentation : Collect and analyze validation data, ensuring accuracy and completeness. Prepare comprehensive validation reports summarizing results and conclusions. Maintain accurate and organized validation documentation for audit purposes. Compliance Management : Stay current with industry regulations, guidelines, and best practices related to validation. Ensure that validation activities comply with relevant regulatory standards (e. g. , FDA, EMA) and company policies. Collaboration and Communication : Collaborate with other departments, including Quality Assurance, Engineering, and Production, to ensure a holistic approach to validation. Communicate validation status, findings, and recommendations to stakeholders. Continuous Improvement : Identify opportunities for process improvement and efficiency in validation activities. Participate in the development and implementation of corrective and preventive actions.