CSV Validation Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement risk-based validation strategies for new systems, product features, integrations, infrastructure modifications, and customer implementations.

• Define the validation scope based on intended use, system complexity, data integrity impact, product quality risk, and relevant regulatory requirements.

• Create and maintain computerized system validation deliverables, which include validation plans, system descriptions, 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 documentation for retirement/data migration.

• Write clear, objective, and testable acceptance criteria.

• Execute validation protocols while documenting results and supporting evidence.

• Ensure that requirements, risks, tests, defects, and validation evidence are completely traceable.

• Compile validation packages for independent Quality review and approval.

• Apply Computer Software Assurance principles where applicable.

• Validate browser-based applications, cloud services, APIs, databases, edge devices, scientific instruments, and integrated laboratory/manufacturing systems.

• Validate the onboarding of instruments, configuration, communication, data capture, remote operation, and result processing.

• Verify data flows, transformations, mappings, contextualization, unit conversion, storage, retrieval, and synchronization.

• Confirm 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.

• Evaluate system functionality against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and relevant 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 that validation evidence is inspection-ready.

• Conduct validation impact assessments for releases, configuration changes, infrastructure updates, bug fixes, and integration changes.

• Determine the scope of validation and regression testing for changes.

• Support release planning and maintain validation documentation as systems evolve.

• Assist with 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.

• Within the first six months, establish validation deliverables and templates, complete priority validation packages, enhance traceability and impact assessments, remediate documentation gaps, improve audit readiness, and support the maintenance of the platform in a validated state.

⛳️ Requirements

• A minimum of 10 years of computerized system validation experience in pharmaceuticals, biotechnology, life sciences, or another GxP-regulated environment.

• Proven experience in creating and executing end-to-end CSV deliverables.

• Comprehensive knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP expectations, GAMP 5, and ALCOA+ data integrity principles.

• Experience in applying risk-based validation and Computer Software Assurance methodologies.

• Proficient in writing user requirements, risk assessments, validation plans, protocols, traceability matrices, deviations, and validation summary reports.

• Experience in executing and documenting IQ, OQ, and PQ activities when applicable.

• Familiarity with 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 in evaluating software changes and determining the appropriate validation and regression scope.

• Capability to review technical documentation, system architecture, data flows, API specifications, and engineering test evidence.

• Excellent technical writing and documentation abilities.

• Strong analytical and troubleshooting skills.

• Ability to manage multiple validation workstreams and deliverables with minimal supervision.

• Effectiveness in collaborating in a remote, cross-functional environment.

• Strongly preferred: experience validating platforms that integrate cloud software, hardware, edge computing, IoT devices, and scientific instruments.

• Strongly preferred: experience with laboratory instruments utilized 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 utilizing 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 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.