CSV Specialist – Syncade MES

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🕒 Outubro 6

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

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🟠 Sênior

🎁 Marketing de Produto

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CINCO Engineering

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1 - 10 funcionários

💼 Consultoria

🏭 Manufatura

🧬 Biotecnologia

💰 $75.000 Seed Round em 2020-03

Consulting • Manufacturing • Biotechnology

CINCO é uma solução de Gestão de Risco de Qualidade que ajuda as Ciências da Vida a proteger seus pacientes gerenciando os riscos em seus processos de fabricação.

Descrição

• Support validation activities for the Syncade MES, including new implementations, system enhancements, upgrades, and changes • Develop, review, and execute validation documentation in accordance with applicable procedures and regulatory requirements • Prepare and/or execute IQ, OQ, PQ, UAT, and regression testing activities as applicable • Develop and execute test scripts and document test results, deviations, and exceptions • Support requirements gathering and development of User Requirements Specifications (URS), Functional Specifications, and other validation deliverables • Ensure traceability between user requirements, functional requirements, risk assessments, and test cases • Support risk assessments and validation strategy development for Syncade-related systems and processes • Investigate and document validation discrepancies, deviations, and testing issues • Support change control activities associated with Syncade system modifications and enhancements • Collaborate with Manufacturing, Automation, IT, Quality, Engineering, and other cross-functional teams • Ensure validation documentation is complete, accurate, and compliant with applicable GxP, GMP, and data integrity requirements • Participate in validation planning, status meetings, execution activities, and project reviews • Support audits and inspections by providing validation documentation and technical information as required

🎯 Requisitos

• Minimum of 3 years of experience in computer system validation, MES validation, or validation of computerized systems within a regulated environment • Hands-on experience with MES validation or implementation • Experience working in a GMP/GxP-regulated pharmaceutical, biotechnology, or manufacturing environment • Knowledge of computer system validation principles and applicable regulatory expectations • Experience developing and executing validation test scripts and documenting results • Familiarity with risk-based validation methodologies and change control processes • Strong technical writing and documentation skills • Ability to work effectively with cross-functional teams and communicate with technical and business stakeholders • Experience with Syncade system configuration, integration, or troubleshooting • Knowledge of MES functionality related to manufacturing, electronic batch records, materials, equipment, or production processes • Experience with 21 CFR Part 11, data integrity principles, and applicable GxP requirements • Familiarity with GAMP 5 and risk-based computerized system validation approaches • Experience supporting system upgrades, remediation, or continuous improvement initiatives