CSV Validation Engineer

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🔴 Lead

👷🏻‍♀️ Engineer

👻 Ghost score 15%

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Genovice

WebsiteLinkedInAll Job Openings

1 - 10 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Genovice is a dedicated staffing agency specializing in the Life Sciences and Healthcare Technology industries. Founded by industry experts, Genovice focuses on connecting companies with highly skilled professionals who meet both technical and cultural needs in fields such as biotechnology, pharmaceuticals, and healthcare technology. With a commitment to quality placements and a personalized approach, the agency ensures candidates not only meet technical qualifications but also align with company values and goals, making them a trusted partner in staffing solutions.

📋 Description

• Develop and execute risk-based validation strategies for new systems, product features, integrations, infrastructure changes, and customer implementations • Define validation scope based on intended use, system complexity, data-integrity impact, product-quality risk, and applicable regulatory requirements • Create and maintain computerized system validation deliverables, including validation plans, system and intended-use descriptions, requirements and specifications, data-flow and interface documentation, risk assessments, test plans and protocols, IQ/OQ/PQ documentation, traceability matrices, deviation records, summary reports, and retirement/data-migration documentation • Author clear, objective, and testable acceptance criteria • Execute validation protocols and document results and supporting evidence • Ensure requirements, risks, tests, defects, and validation evidence are fully traceable • Assemble validation packages for independent Quality review and approval • Apply Computer Software Assurance principles where appropriate • Validate browser-based applications, cloud services, APIs, databases, edge devices, scientific instruments, and integrated laboratory/manufacturing systems • Validate instrument onboarding, configuration, communication, data capture, remote operation, and result processing • Verify data flows, transformations, mappings, contextualization, unit conversion, storage, retrieval, and synchronization • Verify integrations with LIMS, MES, ELN, QMS, and other customer systems • Assess and test interface, interruption, recovery, backup, restore, business-continuity, and disaster-recovery risks and controls • Assess system functionality against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and applicable Asia-Pacific expectations • Validate electronic records, electronic signatures, audit trails, identity/authentication, role-based access, security, date/time controls, review/approval, retention, archival, availability, migration, backup, and recovery controls • Apply ALCOA+ principles and ensure inspection-ready validation evidence • Perform validation impact assessments for releases, configuration changes, infrastructure updates, bug fixes, and integration changes • Determine validation and regression scope for changes • Support release planning and maintain validation documentation as systems evolve • Support periodic reviews, deviation/incident/CAPA/security-event assessments, system retirement, migration, archival, and decommissioning • Coordinate validation activities across Engineering, Product, Operations, Quality, suppliers, and customer teams • Review engineering tests and results for validation evidence leverage • Support supplier assessments • Prepare documentation for audits and regulatory inspections, participate in audit interviews, support responses to observations, and complete corrective actions • During the first six months, establish validation deliverables and templates, complete priority validation packages, improve traceability and impact assessments, remediate documentation gaps, strengthen audit readiness, and support maintaining the platform in a validated state

🎯 Requirements

• At least 10 years of computerized system validation experience in pharmaceutical, biotechnology, life sciences, or another GxP-regulated environment • Demonstrated experience personally creating and executing end-to-end CSV deliverables • Strong working knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP expectations, GAMP 5, and ALCOA+ data-integrity principles • Experience applying risk-based validation and Computer Software Assurance approaches • Experience writing user requirements, risk assessments, validation plans, protocols, traceability matrices, deviations, and validation summary reports • Experience executing and documenting IQ, OQ, and PQ activities where applicable • Experience validating configurable software, SaaS applications, cloud platforms, laboratory systems, manufacturing systems, or integrated technologies • Strong understanding of electronic records, electronic signatures, audit trails, access controls, backup, recovery, security, retention, and archival requirements • Experience evaluating software changes and determining appropriate validation and regression scope • Ability to review technical documentation, system architecture, data flows, API specifications, and engineering test evidence • Excellent technical writing and documentation skills • Strong analytical and troubleshooting abilities • Ability to manage multiple validation workstreams and deliverables with limited supervision • Ability to collaborate effectively in a remote, cross-functional environment • Strongly preferred: experience validating platforms combining cloud software, hardware, edge computing, IoT devices, and scientific instruments • Strongly preferred: experience with laboratory instruments used in pharmaceutical manufacturing or controlled environments • Strongly preferred: experience validating integrations with LIMS, MES, ELN, or QMS platforms • Strongly preferred: familiarity with REST APIs, relational databases, SQL, MQTT, and asynchronous messaging • Strongly preferred: experience validating data transformations, field mappings, unit conversions, and multi-vendor data formats • Strongly preferred: experience working within an Agile software-development lifecycle • Strongly preferred: experience leveraging automated engineering tests as validation evidence • Strongly preferred: familiarity with infrastructure qualification and cloud supplier assessment • Strongly preferred: experience supporting customer-specific configurations and system deployments • Strongly preferred: experience with Japanese PMDA expectations or other Asia-Pacific authorities operating within or aligned with PIC/S frameworks • Strongly preferred: experience participating in customer audits or regulatory inspections • Strongly preferred: familiarity with deviation management, CAPA, change control, document control, and periodic review processes

🏖️ Benefits

• Remote position • Contract role