Computer System Validation Engineer
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**Job Description:** * We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross\-functionally to lead and execute validation activities for GxP electronic systems and applications. * The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle. * The primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements.
**Roles \& Responsibilities:** * Author, review, and/or approve applicable CSV documentation. * Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures. * Assist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations. * Support validation activities for Manufacturing Execution Systems (MES). * Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs. * Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices. * Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments. * Utilize IT service management platforms to support incident, problem, and change management activities. * Work with Business Quality Management Systems and related validation processes.
**Requirements:** * Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience. * Minimum 4\+ years of direct experience in Computer System Validation (CSV). * Strong knowledge of GAMP and risk\-based validation approaches. * Good understanding of electronic records and electronic signatures. * Strong knowledge of Manufacturing Execution System (MES) validation. * Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch. * Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs. * Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing. * Experience with IT service management platforms such as ServiceNow. * Exposure to Business Quality Management Systems such as Veeva.
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