Equipment Validation Specialist

Eurofins; West Point (PA); Vor Ort; USD 85.000 - 120.000; Vollzeit

Benefits dieser Stelle

Medical benefits

401(k) with match

Paid vacation

Holidays

Bonus opportunity

Zusammenfassung

Eurofins is seeking an Equipment Validation Specialist II to drive validation and lifecycle management of laboratory automation in a regulated clinical/research environment. You will lead validation activities, develop comprehensive documentation, and support AI/ML-enabled automation improvements.

The role emphasizes cross-functional collaboration with vendors and technical teams, ensuring GxP compliance and quality standards while advancing automation capabilities within a 1st Shift schedule in

Qualifikationen

• Experience supporting equipment validation in a regulated environment.
• Strong knowledge of validation methodologies, change control, and documentation.
• Ability to troubleshoot and write clear technical reports.

Aufgaben

• Lead installation, commissioning, and deployment of laboratory automation and robotic systems.
• Develop IQ/OQ/PQ protocols, test scripts, validation reports, and traceability docs.
• Support lifecycle management and change control for automation platforms.
• Create data collection, reporting, and dashboards for performance metrics.
• Prepare training materials and SOPs for new automation platforms.
• Support regulatory inspections and audits as required.

Kenntnisse

Automation knowledge

GxP understanding

Technical writing

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Engineering/Automation/Robotics/CS/Life Sciences

Jobbeschreibung

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

Job Description

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.
• 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.

Qualifications

Basic Minimum Qualifications:

• Bachelor’s degree in Engineering, Automation, Robotics, Computer Science, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.
• Experience supporting equipment validation and qualification activities in a regulated environment.
• Knowledge of GxP requirements, validation methodologies, and change control processes.
• Experience with laboratory automation, robotics, or automated instrument platforms.
• Strong technical writing and documentation skills.
• Demonstrated troubleshooting and problem-solving abilities.
• Ability to work effectively across technical, operational, and quality functions.
• Authorization to work in the Unitied States indefinitely without restriction or sponsorship

Preferred Qualifications:

• Experience supporting pharmaceutical, biotechnology, clinical, or laboratory operations.
• Knowledge of computerized systems validation (CSV).
• Experience with automation controls, robotics integration, or laboratory information systems.
• Familiarity with data visualization and reporting platforms.
• Exposure to AI/ML-enabled laboratory automation technologies.
• Experience supporting lifecycle management programs for regulated equipment.

Additional Information

This role is a full-time, permanent positionMonday-Friday1st Shift. Candidates currently located within commutable distance to West Point, PAare 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.