Computer System Validation (CSV) Engineer

Job Description

As a Computer System Validation (CSV) Engineer, your role involves ensuring that computerized systems used in regulated environments are validated in compliance with regulatory requirements such as 21 CFR Part 11, Annex 11, and GAMP 5. You will be responsible for developing and executing validation strategies, creating and maintaining validation documents, ensuring compliance with regulations, collaborating with cross-functional teams, performing impact assessments, and supporting data integrity initiatives.Key Responsibilities:- Develop and execute validation strategies and plans for new and existing computerized systems.- Create and maintain validation documents including User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Validation Plans (VP), IQ/OQ/PQ Protocols and Reports, and Traceability Matrix.- Ensure compliance with FDA regulations, EMA guidelines, and GAMP 5 standards.- Collaborate with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure system functionality meets business and regulatory needs.- Perform impact assessments and change control activities for validated systems.- Support data integrity initiatives and ensure systems comply with 21 CFR Part 11 requirements.- Provide training and guidance on CSV processes and best practices.- Maintain validation documentation in alignment with company procedures and regulatory expectations.Qualification Required:- Bachelors degree in engineering, Computer Science, Life Sciences, or related field.Experience Required:- 25 years of experience in CSV within regulated industries (pharma, biotech, medical devices).- Experience with validating systems such as LIMS, MES, ERP, QMS, SCADA, PLCs, and custom applications.Skills & Knowledge:- Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.- Understanding of software development life cycle (SDLC) and risk-based validation approaches.- Excellent documentation, communication, and project management skills.- Familiarity with electronic recordkeeping and audit trail requirements.- Proficient in MS Office and validation software tools (e.g., ValGenesis, MasterControl) is a plus.Preferred Qualifications:- CSV certifications (e.g., ISPE, PDA) or GxP training.- Experience in data integrity assessments and remediation projects.- Familiarity with cloud-based systems and cybersecurity considerations.(Note: The working conditions may vary between on-site or hybrid depending on the organization.) As a Computer System Validation (CSV) Engineer, your role involves ensuring that computerized systems used in regulated environments are validated in compliance with regulatory requirements such as 21 CFR Part 11, Annex 11, and GAMP 5. You will be responsible for developing and executing validation strategies, creating and maintaining validation documents, ensuring compliance with regulations, collaborating with cross-functional teams, performing impact assessments, and supporting data integrity initiatives.Key Responsibilities:- Develop and execute validation strategies and plans for new and existing computerized systems.- Create and maintain validation documents including User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Validation Plans (VP), IQ/OQ/PQ Protocols and Reports, and Traceability Matrix.- Ensure compliance with FDA regulations, EMA guidelines, and GAMP 5 standards.- Collaborate with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure system functionality meets business and regulatory needs.- Perform impact assessments and change control activities for validated systems.- Support data integrity initiatives and ensure systems comply with 21 CFR Part 11 requirements.- Provide training and guidance on CSV processes and best practices.- Maintain validation documentation in alignment with company procedures and regulatory expectations.Qualification Required:- Bachelors degree in engineering, Computer Science, Life Sciences, or related field.Experience Required:- 25 years of experience in CSV within regulated industries (pharma, biotech, medical devices).- Experience with validating systems such as LIMS, MES, ERP, QMS, SCADA, PLCs, and custom applications.Skills & Knowledge:- Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.- Understanding of software development life cycle (SDLC) and risk-based validation approaches.- Excellent documentation, communication, and project management skills.- Familiarity with electronic recordkeeping and audit trail requirements.- Proficient in MS Office and validation software tools (e.g., ValGenesis, MasterControl) is a plus.Preferred Qualifications:- CSV certifications (e.g., ISPE, PDA) or GxP training.- Experience in data integrity assessments and remediation projects.- Familiarity with cloud-based systems and cybersecurity considerations.(Note: The working conditions may vary between on-site or hybrid depend

Keyskills :
21 CFR Part 11SDLCMS OfficeGAMP 5