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.
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.
Numbers & Facts
Location
Raleigh, NC
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Business Solutionsunmatched
Change Managementunmatched
Clinical Supportunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Cross-Functionalunmatched
Delivery Managementunmatched
Documentationunmatched
Documentation Planunmatched
Drug Manufacturingunmatched
ERP (Enterprise Resource Planning)unmatched
GxPunmatched
IT Service Management (ITSM)unmatched
Information Technology & Information Systemsunmatched
Laboratory Systemsunmatched
Manufacturingunmatched
Manufacturing Execution Systems (MES)unmatched
Manufacturing Systemsunmatched
Oracleunmatched
Process Validationunmatched
Quality Managementunmatched
Regulatory Requirementsunmatched
Requirements Managementunmatched
Requirements Validation/Verificationunmatched
Riskunmatched
SAPunmatched
ServiceNowunmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Systems Administration/Managementunmatched
Systems Engineeringunmatched
Test Scriptsunmatched
Validation Documentationunmatched
Validation Planunmatched
Writing Skillsunmatched
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