Key Responsibilities and Required Skills for a Validation Tester

🎯 Role Definition

This role requires a highly detail-oriented and analytical Validation Tester to join our Quality Assurance team. In this pivotal role, you will be the gatekeeper of quality, responsible for the formal validation of our computer systems to ensure they are compliant with industry regulations (such as GxP, 21 CFR Part 11) and function exactly as intended. The ideal candidate is passionate about quality, possesses a deep understanding of the Software Development Life Cycle (SDLC) in a regulated setting, and excels at creating comprehensive documentation that can withstand the scrutiny of internal and external audits. You will be instrumental in safeguarding our product integrity and ensuring our systems are fit for purpose.

📈 Career Progression

Typical Career Path

Entry Point From:

QA Analyst / Software Tester
IT Support Specialist (in a regulated industry)
Technical Writer (with a focus on SOPs and validation docs)

Advancement To:

Senior Validation Engineer / Senior Validation Specialist
QA Lead / Test Lead
Validation Manager
Quality Systems Manager

Lateral Moves:

Business Systems Analyst
Quality Engineer
Compliance Specialist

Core Responsibilities

Primary Functions

Develop, review, and execute comprehensive software validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Author and maintain detailed, clear, and accurate test plans, test cases, and test scripts based on user requirements, functional specifications, and design documents.
Meticulously document all testing activities, including test execution records, evidence of testing (screenshots), and any deviations from the expected results.
Perform thorough risk assessments in collaboration with cross-functional teams to identify potential failure modes and their impact on business processes and patient safety.
Ensure full traceability from system requirements through to test cases and test results by creating and managing a Traceability Matrix.
Identify, document, and track defects and issues to resolution using designated bug tracking systems like Jira or HP ALM, and verify fixes in subsequent releases.
Author, review, and approve validation lifecycle documentation, including the Validation Plan (VP), User/Functional Requirements Specifications (URS/FRS), and the final Validation Summary Report (VSR).
Execute both manual and automated test scripts to verify the functionality, performance, and reliability of software applications and computer systems.
Conduct rigorous regression testing to ensure that new code changes or system updates have not adversely affected existing functionalities.
Ensure all validation activities and documentation are in strict compliance with internal Standard Operating Procedures (SOPs) and external regulations (e.g., FDA 21 CFR Part 11, Annex 11, GxP).
Participate in peer reviews of test cases, test scripts, and other validation deliverables to ensure quality and adherence to standards.
Collaborate closely with developers, business analysts, project managers, and end-users to understand requirements and resolve complex technical issues.
Support the maintenance of the validated state of systems through periodic reviews, change control procedures, and impact assessments for system modifications.
Provide support during internal and external regulatory audits (e.g., by the FDA) by retrieving validation documentation and explaining testing methodologies.
Analyze and interpret test results to provide clear, data-driven reports on system quality and readiness for release to production environments.
Develop and maintain a deep understanding of the business processes supported by the validated systems to create more effective and relevant test scenarios.
Manage and maintain the test environments, including data setup, configuration, and user account management, to ensure they accurately reflect production settings.
Investigate and troubleshoot system issues, working with technical teams to identify the root cause and ensure a permanent solution is implemented.
Contribute to the continuous improvement of the validation methodology, processes, and standard operating procedures within the Quality department.
Assist in training end-users on newly validated systems and functionalities to ensure proper usage and adherence to established procedures.

Secondary Functions

Support ad-hoc data requests and exploratory data analysis to investigate potential issues.
Contribute to the organization's data governance and quality strategy.
Collaborate with business units to translate evolving data and compliance needs into new engineering and validation requirements.
Participate in sprint planning, retrospectives, and other agile ceremonies within the broader technology team.

Required Skills & Competencies

Hard Skills (Technical)

Computer System Validation (CSV): Profound knowledge of CSV principles and methodologies within a regulated GxP framework.
Regulatory Compliance: In-depth understanding of GxP (GMP, GCP, GLP) regulations, FDA 21 CFR Part 11, and EudraLex Annex 11.
SDLC/STLC: Strong experience with all phases of the Software Development Life Cycle and Software Testing Life Cycle, particularly waterfall and V-model.
IQ/OQ/PQ Protocol Development: Proven ability to write and execute formal Installation, Operational, and Performance Qualification protocols.
Test Management Tools: Proficiency with tools such as HP ALM (Application Lifecycle Management), Micro Focus ALM/QC, Jira with testing plugins (e.g., Zephyr, Xray).
Test Plan & Case Design: Expertise in designing, authoring, and executing detailed test plans, test cases, and test scripts from requirements.
Defect Management: Skilled in using defect tracking systems to log, monitor, and report on software bugs and their resolution.
SQL Queries: Basic to intermediate ability to write SQL queries for data verification and back-end testing.
Technical Documentation: Exceptional ability to write clear, concise, and defensible validation documentation (VPs, VSRs, Traceability Matrices).
Risk Assessment Methodologies: Familiarity with risk analysis techniques (e.g., FMEA) as they apply to software and systems.

Soft Skills

Meticulous Attention to Detail: An exceptional eye for detail is paramount to ensure accuracy in documentation and testing.
Analytical & Problem-Solving Skills: Strong ability to analyze complex systems, identify discrepancies, and troubleshoot issues methodically.
Excellent Written and Verbal Communication: Ability to clearly articulate technical issues, test results, and compliance risks to both technical and non-technical audiences.
Collaboration and Teamwork: A proven team player who can work effectively with cross-functional teams to achieve common goals.
Time Management & Organization: Excellent organizational skills with the ability to manage multiple validation projects simultaneously and meet tight deadlines.
Critical Thinking: The ability to think critically about system functionality and user workflows to identify potential issues beyond the written requirements.
Adaptability: Flexibility to adapt to changing priorities, project scopes, and new technologies in a dynamic environment.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in a technical or scientific field.

Preferred Education:

Bachelor's or Master's degree in Computer Science, Engineering, or a Life Sciences discipline.

Relevant Fields of Study:

Computer Science / Information Technology
Biology / Chemistry / Biotechnology
Engineering

Experience Requirements

Typical Experience Range:

3-7 years of direct experience in a Computer System Validation or Software Quality Assurance role within a regulated industry.

Preferred:

Direct, hands-on experience in a GxP environment (pharmaceutical, medical device, or biotech) is strongly preferred. Experience facing regulatory audits (e.g., FDA, EMA) is a significant plus.