Senior Validation Engineer

Job Title: Validation Engineer

Overview

We are seeking an experienced Instrument Software Validation Analyst to ensure that laboratory, manufacturing, and embedded software systems operate reliably, compliantly, and in accordance with regulatory requirements (GxP/FDA/EMA). The role focuses on maintaining validated systems through structured validation processes (IQ/OQ/PQ) and serves as a bridge between technical software testing and regulatory compliance.

Key Responsibilities

Software Validation & Compliance

• Validate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelines
• Develop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Ensure systems remain in a validated state throughout their lifecycle

Documentation & Regulatory Support

• Author and maintain validation documentation including:
• Validation Plans and Reports
• User Requirement Specifications (URS)
• Functional/Design Specifications
• Traceability Matrices
• Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards

System Analysis & Design

• Gather and document system requirements
• Develop software specifications and validation test cases
• Create infrastructure diagrams and data flow documentation
• Document current-state software configurations

Testing & Execution

• Perform functional, integration, regression, and data integrity testing
• Identify, document, and troubleshoot validation deviations
• Conduct root cause analysis and collaborate with cross-functional teams to resolve issues

Risk & Change Management

• Conduct risk assessments (e.g., FMEA) to identify and mitigate system risks
• Support and implement change control procedures for software updates and enhancements
• Transition legacy SOPs to updated IT software management SOPs

Required Qualifications

• Education: Bachelor s degree in Computer Science, Engineering, Life Sciences, or related field
• Experience: 2 5+ years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices)

Required Skills & Competencies

Regulatory Knowledge

• 5+ years of strong understanding of:
• FDA, EMA, and GMP regulations
• 21 CFR Part 11
• GAMP 5 guidelines
• Data integrity principles

Technical Expertise

• 3 to 5 years of experience with:
• Laboratory systems such as LIMS
• Chromatography Data Systems (e.g., Empower)
• Familiarity with validation lifecycle and documentation standards

Core Competencies

• Strong analytical and problem-solving skills
• Excellent technical writing and documentation abilities
• Attention to detail with a quality-focused mindset
• Ability to work cross-functionally with IT, QA, and business teams

Preferred Qualifications

• Experience in global regulatory environments
• Exposure to instrument software in laboratory or manufacturing settings
• Knowledge of SOP migration and system lifecycle management