System Validation Engineer
Aviso de fuente externaen Ampstek
Ampstek seeks a System Validation Engineer with life sciences experience in computerized system validation, risk and test management, and audits.
Salario
No especificado
Ubicación
Heredia, Costa Rica
Tipo de empleo
Tiempo completo
Modalidad
No especificado
System Validation Engineer
Heredia, Costa Rica
Descripción del empleo
About the role
Ampstek is looking for people with proven success in computerized system validation or computerized system assurance, risk management, test management, and audits.
Requirements
- Five to ten years of professional experience in the life sciences industry, working for a consulting services organization and/or industry.
- Good understanding of pharmaceutical compliance regulations, including 21 CFR Part 11, GxP, and GAMP 5.
- Experience creating, reviewing, and approving or acknowledging validation deliverables.
- Strong knowledge of software development life cycle, testing methodologies, risk-based testing, requirement traceability, defect lifecycle management, and quality assurance processes.
- Ability to analyze business and functional requirements and identify quality risks.
- Knowledge of risk management processes and quality management requirements that ensure IT projects meet quality and regulatory requirements.
- Experience validating enterprise applications such as SAP / S4 HANA projects, Veeva, Trackwise, QMS, and DMS; laboratory applications such as LIMS and MODA; and manufacturing applications such as SCADA and MES.
- Functional knowledge of domain applications such as clinical applications, including EDC and CTMS, regulatory applications such as CDR, or other applications or systems used in the pharmaceutical industry.
- Thorough knowledge of compliance and validation concepts, including change, deviation, and supplier management.
- Experience with agile and waterfall methodologies.
- Knowledge and hands-on experience conducting periodic or control maturity assessments and audits.
- Knowledge of SaaS/cloud qualifications and validation tools and templates used in the pharmaceutical industry, such as Kneat, ServiceNow, and Veeva.
- Proven ability to support multiple projects and respond quickly to changing situations in complex environments.
Datos clave
- Requires five to ten years of professional experience in the life sciences industry.
- The role covers computerized system validation or assurance, risk management, test management, and audits.
- Knowledge of 21 CFR Part 11, GxP, and GAMP 5 is required.
Preguntas frecuentes
What does the System Validation Engineer role involve?
The role focuses on computerized system validation or assurance, risk management, test management, and audits.
What experience and knowledge are required?
The listing asks for five to ten years of professional experience in the life sciences industry and a good understanding of 21 CFR Part 11, GxP, and GAMP 5.
What applications may the role involve validating?
Examples include enterprise applications such as SAP / S4 HANA projects, laboratory applications such as LIMS, and manufacturing applications such as SCADA and MES.