Automation & Robotics Equipment Validation Specialist

Position Summary:
The Equipment Validation Specialist is responsible for supporting the implementation, validation, maintenance, and continuous improvement of laboratory automation and robotic systems within a regulated GxP environment. This role partners closely with laboratory operations, automation engineers, quality, validation, and IT stakeholders to ensure robotic platforms operate reliably, compliantly, and efficiently while enabling future digital and AI-driven laboratory capabilities.
Key Responsibilities:
Automation & Robotics Implementation
Support implementation and integration of automation solutions for laboratory platform technologies.
Assist in connecting automated systems and robotic equipment to laboratory workflows and operational requirements.
Configure, test, and verify robotic and automation systems to ensure intended performance.
Collaborate with cross-functional teams to deploy new automation capabilities supporting laboratory modernization initiatives.
Validation & Compliance
Author, execute, and maintain equipment validation documentation, including qualification and testing protocols.
Develop and manage Change Control documentation associated with automation systems.
Ensure automation platforms remain in a validated state throughout their lifecycle.
Support compliance with FDA regulations, GxP requirements, and company quality standards.
Participate in audits, inspections, and quality reviews as required.
System Lifecycle Management
Execute lifecycle management activities for automated laboratory systems.
Monitor system performance and support preventative maintenance strategies.
Maintain documentation, system inventories, and validation records.
Support upgrades, enhancements, and continuous improvement efforts.
Troubleshooting & Investigations
Diagnose and resolve equipment, automation, and system integration issues.
Perform root cause analysis and implement corrective and preventive actions (CAPA).
Support investigations involving automation systems and develop corrective actions.
Partner with vendors and internal stakeholders to address technical issues and system performance concerns.
Data Analytics & Digital Enablement
Develop reporting, analytics, and visualization solutions supporting laboratory operations and business processes.
Leverage operational data to identify opportunities for process optimization and performance improvements.
Support evaluation and deployment of emerging AI/ML capabilities as they become available for laboratory automation platforms.
Basic Mimimum Qualifications:
Bachelor's degree in Engineering, Life Sciences, Computer Science, Biotechnology, Automation Engineering, or a related technical discipline.
Experience supporting automated laboratory equipment, robotics, manufacturing systems, or regulated instrumentation.
Knowledge of validation lifecycle principles and GxP regulations.
Experience authoring technical documentation, validation protocols, test scripts, and change controls.
Strong troubleshooting and root cause analysis skills.
Excellent written and verbal communication skills.
Ability to work effectively in cross-functional teams.
Preferred Qualifications:
Experience in pharmaceutical, biotechnology, or regulated laboratory environments.
Familiarity with FDA and global regulatory requirements for computerized or automated systems.
Experience with laboratory automation platforms, robotics integration, or laboratory information systems.
Knowledge of data visualization, reporting tools, and analytics platforms.
Exposure to AI/ML-enabled laboratory technologies and digital automation strategies.

Employment type
Full-time

Work arrangement
No