QA Validation Professional – P2

Overview

Supports quality systems activities for software validation at Cepheid, focusing on design control and risk management in line with FDA and ISO regulations. This is an on-site individual contributor role reporting to the Associate QA Manager.

What you'll do

• Plan, execute, review and document validation activities for Product Software Systems and Computer Systems.
• Perform duties as an individual contributor and/or team member with 100% hands-on work.
• Create, review and manage validation deliverables including Validation Master Plans (VMPs), risk assessments, protocols, test plans, traceability matrices and validation reports.
• Ensure compliance with internal procedures and applicable regulatory requirements.
• Design, document, execute and review functional, integration and user acceptance testing (UAT) activities.
• Analyze test results, generate validation evidence and support validation report completion in accordance with SOPs.
• Record, investigate, verify and report software defects to ensure accurate representation of software requirements and support timely resolution of design and implementation issues.
• Work closely with Software Engineering and cross-functional teams to identify, resolve and verify design issues and software defects.
• Manage documentation changes through the document control system, conduct test design reviews and risk assessments, support Product Lifecycle Application Management activities, drive quality improvements through stakeholder collaboration, and actively participate in daily management using DBS tools.

What you'll need

• BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical Engineering, or a related field.
• 3+ years of Computer System Validation (CSV) and/or Product Software Validation experience in a regulated environment.
• Strong understanding of regulatory and quality requirements, including FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, ISO standards, design controls, risk management, and software validation principles.
• Hands-on experience with validation and testing activities, including Windows environments, web application testing, SQL query execution and analysis, troubleshooting, defect management, and validation deliverable development.
• Excellent communication, analytical and leadership skills, with the ability to quickly learn new technologies, drive product quality and customer satisfaction, mentor less experienced team members, and independently lead small to medium validation projects.

Nice to have

• Software Development Life Cycle (SDLC) methodologies (Agile, Waterfall) and validation of systems such as LIMS, MES, ERP, Cloud or enterprise software platforms.
• Computer Software Assurance (CSA) implementation, risk-based validation approaches, and transition from traditional CSV practices to CSA methodologies.
• AI/ML-enabled applications, cloud-based solutions, Product Lifecycle Management (PLM/ALM) systems, and participation in regulatory inspections or quality audits as a validation subject matter expert.

Details

• Location: Bengaluru (IDC), India.
• On-site role.
• Part of Cepheid - Software Test Engineering - QA.