Computer System Validation Engineer

Job Summary:

• 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.

• 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.

• 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 E  systems such as Info Batch.
• 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 Service Now.
• Exposure to Business Quality Management Systems such as Veeva.