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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