Computer Validation Analyst II

The Computer Validation Analyst II is responsible for ensuring that computerized systems used within the organization comply with regulatory requirements and internal quality standards. This role involves planning, executing, and documenting validation activities for software applications and other computerized platforms. The analyst collaborates with cross-functional teams to maintain compliance throughout the system lifecycle.

Main Duties & Responsibilities:

This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in consultation with the incumbent.
•    Review user/system requirements and provide input to ensure validation activities meet business and regulatory needs.
•    Actively contribute to validation planning and assist in performing risk assessments.
•    Prepare and review of validation documentation, including test cases and OQ/PQ, ensuring compliance with SOPs and standards.
•    Perform Ad-hoc testing, Build Verification Testing (BVT) and Regression Testing to confirm system stability and functionality after changes or updates.
•    Create or update relevant testing artifacts and coordinate execution of validation activities to ensure compliance with change control procedures.
•    Manage the defect lifecycle end-to-end: triage, coordinate fixes with dev teams, retest, and close with complete documentation.
•    Provide assistance in validation documentation packages to ensure accuracy and compliance.
•    Automate test cases using suitable frameworks, design for accuracy and execution speed with guidance.
•    Provide guidance and support to junior team members during validation activities.
•    Engage in continuous learning and support additional tasks as assigned.
•    Perform additional duties as assigned or requested, contributing to team success and project delivery.

Minimum Education & Experience: 

•    Bachelor’s degree in engineering or science
•    Minimum 3+ years of experience in Computer System Validation preferably from regulated environment like pharmaceutical, biotech, or medical device industry.
•    Strong understanding of software development and testing methodologies.
•    Proficiency in SQL for data validation, querying, and analysis within validation processes.
•    Proficiency in BI tools like Tableau, or similar for monitoring study KPIs. 
•    Ability to analyze requirements and translate them into effective test scenarios.
•    Excellent problem solving and communication skills.
•    Experience with project and test management tools (e.g., JIRA, XRay). 
•    Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

Knowledge, Skills, and Competencies:

•    Communication (verbal & written)  
Conveys thoughts in a clear, concise, and accurate manner. Provides appropriate status on all work and projects.  
•    Customer service  
Ensure customer focus is at the center of daily activities. Provide the highest quality services through efficient and compliant processes. Strive to constantly and consistently exceed the needs of the customer to ensure customer delight.
•    Quality  
Embraces a standard of excellence and a rigorous adherence to laws and regulations which govern our industry.  
•    Problem-solving & decision making  
Takes ownership of problem resolution. Adequately engages in due diligence, seeks input from others, and makes informed and sound judgments as appropriate.  
•    Relationship building
Maintains positive relationships with colleagues. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people.