[Hiring] Senior Computerized System Validation Engineer @Genovice

Role Description

This is a remote position.

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
• 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.

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, 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

Requirements

• 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

Company Description