Validation Engineer

Overview

Manage validation and compliance of lab instruments & computer systems in GMP environment

Key Responsibilities

• validation
• compliance
• data integrity
• risk assessment
• system administration
• training

Tasks

-Manage qualification, validation, and periodic review activities for laboratory instruments and computerized systems. -Ensure all laboratory activities are conducted in full compliance with cGMP and applicable quality system requirements. -Ensure all computerized systems are implemented and maintained in compliance with data integrity principles, GMP regulations, and internal policies. -Lead and participate in risk assessments and continuous improvement initiatives to enhance system reliability and compliance. -Collaborate with IT, validation, and QC personnel on change controls, deviations, and investigations. -Foster effective working relationships with internal and external stakeholders. -Implement and maintain robust data backup and disaster recovery strategies for critical laboratory systems. -Maintain current knowledge of regulatory expectations and best practices related to data integrity and computerized system validation. -Ensure continued GxP compliance of QC laboratory computer systems and software. -Act as a key laboratory resource for audit/inspection readiness activities; presenting data integrity and system management processes during regulatory inspections. -Author and review documentation including SOPs, user requirements, system specifications, and validation protocols. -Serve as a subject matter expert and system administrator for QC laboratory instruments and computerized systems, including analytical and microbiological equipment. -Provide training to QC staff on the operation and administration of laboratory computerized systems. -Troubleshoot instrumentation/system issues and coordinate resolution with internal teams or external vendors. -Contribute to regulatory inspection readiness through proactive compliance and documentation practices.

Requirements

• fda
• audit
• engineering
• life sciences
• computer science
• master's

What You Bring

-Audit and FDA experience. -Education in Engineering, Life Sciences, Computer Science, or a related field is required. Master’s degree preferred. -Understanding of full compliance for lab instrumentation, validation protocols, FDA compliance, audit, lab equipment, IQ, OQ, PQ.

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About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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