Role and Responsibilities:
As a Computer System Validation (CSV) Specialist based in Dallas, TX, you will be responsible for overseeing the validation of laboratory and manufacturing systems to ensure compliance with regulatory standards and internal quality policy.
You will lead CSV activities for systems such as Empower3 and LabX, ensuring adherence to Good Automated Manufacturing Practice (GAMP 5), FDA data integrity requirements, and 21 CFR Part 11. You will collaborate cross-functionally with Quality, IT, and Operations teams to ensure timely and compliant validation execution.
Your role will also involve continuous improvement of validation processes and maintaining validated states for all computerized systems.
System Validation Management:
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Oversee validation of laboratory systems including Empower3 and LabX in accordance with GAMP 5 and 21 CFR Part 11.
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Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
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Lead Computerized Systems Validation (CSV) projects from planning through final reporting, ensuring regulatory compliance.
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Conduct risk assessments using Failure Mode and Effects Analysis (FMEA) to identify and mitigate validation risks.
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Collaborate with QA, QC, IT, and Operations to maintain validated system status and ensure smooth audit readiness.
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Provide technical expertise for new system implementations, upgrades, and ongoing maintenance.
Compliance and Continuous Improvement:
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Ensure all validation deliverables meet FDA, GAMP 5, and 21 CFR Part 11 standards.
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Support internal and external audits by preparing and maintaining complete validation documentation.
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Identify opportunities to optimize CSV processes and enhance overall system performance.
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Drive continuous improvement initiatives for laboratory and manufacturing system validation activities.
Required Skills:
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Bachelor’s degree in a scientific or engineering discipline (or equivalent experience) required.
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Minimum 4+ years of experience in Computer Systems Validation (CSV) for laboratory and manufacturing systems.
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Strong understanding of GAMP 5, FDA data integrity, and 21 CFR Part 11 requirements.
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Experience with risk assessment methodologies (FMEA) and validation lifecycle documentation.
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Knowledge of laboratory systems such as Empower3, LabX, or other chromatography/data acquisition systems.
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Proven ability to collaborate with Quality Operations, QA/QC, and IT teams.
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Experience preparing, executing, and reviewing IQ/OQ/PQ protocols.
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Strong analytical and documentation skills with attention to detail.
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Experience supporting new system implementations and maintaining validated systems.