GxP Validation Specialist, Computerized Systems

TechDigital Group; New Jersey; On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Validation Specialist for Computerized Systems to ensure compliance with GxP standards. In this pivotal role, you will be responsible for performing initial and routine validation activities, including qualification of laboratory instruments and troubleshooting system-related issues. You will work closely with engineering teams and end users to develop life cycle documents, execute validation studies, and defend protocols during audits. This position offers a unique opportunity to contribute to high-quality standards in a classified manufacturing environment while enhancing your career in a dynamic and supportive setting.

Qualifications

• Bachelor's degree preferred and 8 years of relevant work experience required.
• Strong understanding of validation concepts and regulatory requirements.

Responsibilities

• Perform validation document generation and protocol execution activities.
• Execute validation studies and write protocol summaries and reports.
• Collaborate with departments and external service providers.

Skills

Validation concepts

Communication skills

cGMP knowledge

Critical reasoning

Regulatory requirements knowledge

Teamwork

Time management

Microsoft Office Suite

Education

Bachelor's degree in Science or Engineering

8 years relevant work experience

Tools

Microsoft Word

Microsoft Outlook

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Job description

Required Skills & Experience
• 5-10 years of embedded software experience
• Hands-on expertise with Yocto Linux build systems and ARM-based embedded platforms (NXP i.MX6 or similar)
• Working knowledge of systemd service management, hardware watchdog integration, and Linux OS optimization
• Familiarity with ASP.NET Core microservices and lightweight IPC frameworks such as ZeroMQ or D-Bus
• Experience working in regulated industries (medical devices, life sciences, or similar) is preferred

Responsibilities
• Optimize embedded software solutions using ZeroMQ, ActiveMQ, Embedded Linux, C#, and PostgreSQL, ensuring performance, reliability, and maintainability.
• Drive integration and communication strategies between microservices, legacy applications, and embedded systems using messaging frameworks and API-based architectures.
• Optimize system performance and operational excellence through database tuning, messaging optimization, observability, monitoring, logging, and proactive incident analysis.
• Expertise on code reviews, risk management, technical documentation, and guidance on Yocto-based Linux platforms.
• Collaborate with cross-functional Agile teams to ensure technical feasibility, support delivery roadmaps, and continuously improve solution quality and reliability. --
--