Position Summary:
The Equipment Validation Specialist II is responsible for the implementation, validation, lifecycle management, and continuous improvement of laboratory automation and robotic platforms within a regulated clinical and research environment. This role supports the deployment of advanced automation technologies, including robotic systems and multi-functional robotic arms, while ensuring compliance with applicable GxP requirements and validation standards.
The successful candidate will lead equipment validation activities, support change control processes, develop technical documentation, troubleshoot automation systems, and build reporting solutions that enable operational excellence and data-driven decision-making. The position plays a key role in maintaining automation systems in a validated state while advancing future automation and AI/ML-enabled capabilities.
Key Responsibilities:
Automation & Robotics Implementation
- Lead the installation, commissioning, and deployment of laboratory automation and robotic systems.
- Coordinate integration of automation platforms with multi-functional robotic technologies.
- Support implementation of new automation solutions that improve operational efficiency and laboratory performance.
- Collaborate with cross-functional stakeholders, vendors, and technical teams during deployment activities.
Equipment Validation & Compliance
- Author, execute, and/or review validation documentation including:
- Validation Plans
- IQ/OQ/PQ protocols
- Test scripts
- Validation reports
- Traceability documentation
- Develop and maintain equipment qualification and validation strategies.
- Ensure automation equipment remains in a validated state throughout its lifecycle.
- Support regulatory inspections and audits as necessary.
- Ensure compliance with current GxP requirements and internal quality standards.
Change Control & Lifecycle Management
- Initiate, document, and manage change control activities associated with automation systems.
- Evaluate system modifications for validation impact and regulatory implications.
- Support lifecycle management programs for automation platforms and associated infrastructure.
- Develop and implement corrective and preventive actions when required.
Troubleshooting & Continuous Improvement
- Investigate equipment and automation system issues.
- Perform root cause analysis and develop remediation plans.
- Identify opportunities to enhance system reliability, performance, and scalability.
- Support implementation of next-generation capabilities, including AI/ML-enabled automation enhancements as technologies become available.
Data Analytics & Reporting
- Develop reporting, analytics, and visualization solutions that support laboratory operations and business processes.
- Create data collection and reporting systems to monitor equipment performance and operational metrics.
- Design dashboards and reports that support informed decision-making and continuous improvement initiatives.
Documentation & Training
- Develop and maintain technical and operational documentation.
- Create training materials and standard operating procedures for new automation platforms.
- Support knowledge transfer activities and ensure effective onboarding and training for system users.
- Maintain accurate records in accordance with quality and regulatory requirements.