Bachelor's degree in Life Sciences, Engineering, IT, or related field or equivalent experience
Minimum of 4 years in Computer System Validation (CSV)
Strong knowledge of GAMP and risk-based validation
Understanding of electronic records and signatures
Experience with Manufacturing Execution System (MES) validation
Familiarity with MES and ERP systems like Emerson Syncade, SAP, and Oracle
Strong documentation skills in CSV-related deliverables
Responsibilities
Author, review, and approve validation documentation
Assist during test execution and document failures
Help develop requirements for computerized systems
Support validation activities for Manufacturing Execution Systems (MES)
Maintain CSV documentation including Validation Plans and Specifications
Ensure compliance with regulatory requirements
Utilize IT service management platforms for support
Benefits
Opportunity to work with a global pharmaceutical leader
Engage in cross-functional collaboration
Support critical validation processes in biopharmaceuticals
Contribute to compliance with industry regulations
Work in a dynamic and regulated environment
Full Job Description
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.
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.
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.
