Bachelor's degree in Life Sciences, Engineering, IT, or related field, or equivalent experience
Minimum 4 years of hands-on experience in Computer System Validation (CSV)
Strong understanding of GAMP and risk-based validation methodologies
Proficient in handling electronic records and signatures
Experience with Manufacturing Execution System (MES) validation
Familiarity with systems like Emerson Syncade, SAP, Oracle, and InfoBatch
Strong capability in developing essential CSV documentation
Responsibilities
Author, review, and approve CSV documentation
Assist in test execution and document test failures
Support Business Owners in requirements and specifications development for GxP systems
Conduct validation activities for Manufacturing Execution Systems (MES)
Develop and maintain validation documentation including plans and reports
Ensure activities meet cGMP, GxP, and regulatory compliance
Utilize IT service management tools for incident and change management
Benefits
Opportunity to work with a leading global pharmaceutical client
Cross-functional collaboration with Business and Technical Owners
Engage in validation of systems crucial for manufacturings
Exposure to cutting-edge technologies within the pharmaceutical field
Full Job Description
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.
ssist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
ssist 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.
Education & Experience:
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.
