Katalyst CRO
Job Description
We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation. This role is critical in ensuring compliance, validation, and accurate documentation of enterprise applications, particularly in regulated environments (GxP/21 CFR Part 11). Responsibilities
Perform Computer System Validation (CSV) activities for SAP and OpenText systems. Develop and execute validation protocols (IQ, OQ, PQ) in line with industry regulations. Ensure compliance with FDA, GxP, and 21 CFR Part 11 requirements. Collaborate with IT, QA, and business stakeholders to gather requirements and translate them into validation deliverables. Author, review, and maintain validation documentation, technical specifications, and SOPs. Provide technical writing support, including preparation of user guides, technical documentation, and audit-ready records. Support audits and inspections by providing validation evidence and documentation. Qualifications
Experience with Computer System Validation (CSV) for SAP and OpenText systems. Ability to develop and execute validation protocols (IQ, OQ, PQ). Knowledge of FDA, GxP, and 21 CFR Part 11 requirements. Strong collaboration with IT, QA, and business stakeholders to gather requirements and translate them into validation deliverables. Technical writing experience including preparation of user guides, technical documentation, and audit-ready records. Experience supporting audits and inspections with validation evidence and documentation.
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We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation. This role is critical in ensuring compliance, validation, and accurate documentation of enterprise applications, particularly in regulated environments (GxP/21 CFR Part 11). Responsibilities
Perform Computer System Validation (CSV) activities for SAP and OpenText systems. Develop and execute validation protocols (IQ, OQ, PQ) in line with industry regulations. Ensure compliance with FDA, GxP, and 21 CFR Part 11 requirements. Collaborate with IT, QA, and business stakeholders to gather requirements and translate them into validation deliverables. Author, review, and maintain validation documentation, technical specifications, and SOPs. Provide technical writing support, including preparation of user guides, technical documentation, and audit-ready records. Support audits and inspections by providing validation evidence and documentation. Qualifications
Experience with Computer System Validation (CSV) for SAP and OpenText systems. Ability to develop and execute validation protocols (IQ, OQ, PQ). Knowledge of FDA, GxP, and 21 CFR Part 11 requirements. Strong collaboration with IT, QA, and business stakeholders to gather requirements and translate them into validation deliverables. Technical writing experience including preparation of user guides, technical documentation, and audit-ready records. Experience supporting audits and inspections with validation evidence and documentation.
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