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SR CSV Validation Engineer

The Opportunity

A growing technology company serving pharmaceutical and other regulated manufacturing environments is seeking an experienced Senior Computerized System Validation Engineer.

This is a hands-on validation role responsible for planning, developing, executing, and maintaining computerized system validation activities for a technology platform that includes cloud software, edge devices, scientific instrument connectivity, data-processing services, APIs, databases, and integrations with laboratory and manufacturing systems.

The Senior CSV Validation Engineer will translate system functionality and regulatory requirements into practical, risk-based validation deliverables. This person will work closely with Engineering, Product, Quality, and technical subject-matter experts to ensure systems are appropriately specified, tested, documented, and maintained in a validated state.

This role is distinct from independent Quality oversight. The Senior CSV Validation Engineer will prepare and execute validation work, investigate discrepancies, and assemble objective evidence for review and approval by Quality.

Key Responsibilities
Validation Planning and Execution

• 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
    

  • User requirements specifications
    

  • Functional and configuration specifications
    

  • Data-flow and system-interface documentation
    

  • GxP and data-integrity risk assessments
    

  • Validation test plans and protocols
    

  • Installation Qualification documentation
    

  • Operational Qualification documentation
    

  • Performance Qualification documentation, where applicable
    

  • Requirements traceability matrices
    

  • Validation deviation and discrepancy records
    

  • Validation summary reports
    

  • System retirement and data-migration documentation
    

• Author clear, objective, and testable acceptance criteria
  

• Execute validation protocols and accurately document results and supporting evidence
  

• Ensure requirements, risks, tests, defects, and validation evidence are fully traceable
  

• Assemble complete validation packages for independent Quality review and approval
  

• Apply Computer Software Assurance principles where appropriate while maintaining compliance with customer and regulatory expectations
  

Platform and Integration Validation

• Validate systems that combine browser-based applications, cloud services, APIs, databases, edge devices, and scientific instruments
  

• Validate instrument onboarding, configuration, communication, data capture, remote operation, and result processing
  

• Verify data flows from scientific instruments through edge and cloud components into external laboratory or manufacturing systems
  

• Validate data transformation, mapping, contextualization, unit conversion, storage, retrieval, and synchronization
  

• Verify integrations with LIMS, MES, ELN, QMS, and other customer systems
  

• Assess and test interface risks, including:
  

  • Incomplete or malformed data
    

  • Incorrect field mappings
    

  • Duplicate or delayed transactions
    

  • Communication interruptions
    

  • Device disconnection
    

  • Partial processing
    

  • Failed synchronization
    

  • Retry and recovery behavior
    

  • Incorrect timestamps or record attribution
    

• Confirm that system behavior during network or power interruptions does not result in lost, duplicated, corrupted, or incorrectly attributed data
  

• Validate system recovery, backup, restore, business-continuity, and disaster-recovery controls where applicable
  

Part 11, Annex 11 and Data Integrity

• Assess system functionality against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and applicable Asia-Pacific expectations
  

• Validate controls for:
  

  • Electronic records
    

  • Electronic signatures
    

  • Audit trails
    

  • User identity and authentication
    

  • Role-based access
    

  • Security and unauthorized-access prevention
    

  • Date and time controls
    

  • Record review and approval
    

  • Data retention and archival
    

  • Backup and recovery
    

  • System availability
    

  • Data migration
    

• Verify that audit trails accurately capture relevant user activity, system events, changes, timestamps, and record history
  

• Test electronic-signature meaning, attribution, manifestation, security, and linkage to the associated electronic record
  

• Apply ALCOA+ principles throughout validation planning, execution, and documentation
  

• Ensure validation evidence is complete, attributable, legible, contemporaneous, original, accurate, and inspection-ready
  

Change Control and Validated-State Maintenance

• Perform validation impact assessments for software releases, configuration changes, infrastructure updates, bug fixes, and integration changes
  

• Determine the appropriate level of validation and regression evidence for each change
  

• Support release planning by identifying validation dependencies, risks, deliverables, and timelines
  

• Maintain validation documentation as the platform and supporting infrastructure evolve
  

• Support periodic system reviews to confirm that systems remain fit for intended use and in a validated state
  

• Assess deviations, incidents, CAPAs, security events, and known defects for validation impact
  

• Support controlled system retirement, data migration, archival, and decommissioning activities
  

• Ensure open validation discrepancies are appropriately evaluated, documented, resolved, or formally accepted before release
  

Collaboration and Audit Support

• Partner with Engineering and Product teams to make requirements clear, testable, and traceable
  

• Review engineering test plans and results to determine whether existing evidence can be appropriately leveraged for validation
  

• Work with software testers to avoid unnecessary duplication while ensuring GxP risks are adequately covered
  

• Coordinate validation activities across Engineering, Product, Operations, Quality, suppliers, and customer teams
  

• Respond constructively to independent Quality review comments and resolve documentation or evidence gaps
  

• Support supplier assessments for cloud services, software components, infrastructure providers, and other GxP-relevant vendors
  

• Prepare validation documentation for customer audits, supplier audits, and regulatory inspections
  

• Participate in audit interviews and clearly explain validation strategies, risk decisions, test evidence, and system controls
  

• Support responses to audit observations and complete assigned corrective actions
  

Required Qualifications

• 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
    

  • 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 that combine cloud software, hardware, edge computing, IoT devices, and scientific instruments
  

• Experience with laboratory instruments used in pharmaceutical manufacturing or controlled environments
  

• Experience validating integrations with LIMS, MES, ELN, or QMS platforms
  

• Familiarity with REST APIs, relational databases, SQL, MQTT, and asynchronous messaging
  

• Experience validating data transformations, field mappings, unit conversions, and multi-vendor data formats
  

• Experience working within an Agile software-development lifecycle
  

• Experience leveraging automated engineering tests as validation evidence
  

• Familiarity with infrastructure qualification and cloud supplier assessment
  

• Experience supporting customer-specific configurations and system deployments
  

• Experience with Japanese PMDA expectations or other Asia-Pacific authorities operating within or aligned with PIC/S frameworks
  

• Experience participating in customer audits or regulatory inspections
  

• Familiarity with deviation management, CAPA, change control, document control, and periodic review processes
  

What We’re Looking For

The successful candidate understands that validation is more than producing documents. You can understand how a complex system works, identify the functions and data most critical to regulated users, and create proportionate evidence that the system is fit for its intended use.

You are comfortable moving between regulatory requirements and technical details. You can discuss data integrity with Quality, API behavior with Engineering, intended use with Product, and operational workflows with customers.

You produce clear, defensible documentation and do not rely on vague or repetitive test scripts. You know how to challenge requirements, investigate discrepancies, document unexpected results, and distinguish true product risks from low-value documentation exercises.

You are also comfortable working in a growing organization where validation processes are still maturing. You can introduce structure, templates, and discipline while remaining practical and delivery-focused.

What Success Looks Like

During the first six months, the Senior CSV Validation Engineer will:

• Develop a detailed understanding of the platform’s architecture, intended uses, data flows, and GxP-critical functions
  

• Establish consistent, risk-based validation deliverables and templates
  

• Complete validation packages for priority systems, features, and integrations
  

• Improve traceability among requirements, risks, tests, defects, and validation evidence
  

• Establish an effective approach for leveraging engineering testing without compromising Quality independence
  

• Strengthen validation impact assessments for software and infrastructure changes
  

• Identify and remediate gaps in existing validation documentation
  

• Improve the completeness, consistency, and audit readiness of validation records
  

• Support the Quality organization in maintaining the platform in a validated state