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.

Qualifications :

Basic Mimimum Qualifications:

• Bachelors 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.
• Must be eligible to work in the United States indefinitely without restriction or sponsorship.

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.

Additional Information :

This role is a full-time permanent position Monday-Friday 1st Shift. Candidates currently located within commutable distance to West Point PA are encouraged to apply.

Excellent full-time benefits include:

• Comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for yearly goal-based bonus & merit-based increases

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time