QA Validation Professional – P2
Beckman Coulter Diagnostics (company site, opens in a new tab)3+ yrsBengaluruOn-siteDirect career pageEst. 9–16 LPA
Posted 15h ago
Reach people at Beckman Coulter Diagnostics
People at this company you can reach
Log in to see who works here
Create a free account or log in to see the people at Beckman Coulter Diagnostics you could write to:
- Recruiters & HR
- People in this function
- Work addresses
Your match
Against your primary resume
Log in to see your match score
Create a free account or log in to unlock your CV match score across:
- Role fit
- Experience
- Industry relevance
Protocol Intelligence
How competitive this role is
Competition
Background fit
Strictness
Log in to see why each signal reads the way it does.
Job description
Structured overview of role & requirements
About This Role
- Plan, execute, review, and document software validation activities for Product Software Systems and Computer Systems, ensuring compliance with FDA and ISO regulations.
- Create and manage validation deliverables such as Validation Master Plans, risk assessments, protocols, test plans, traceability matrices, and reports.
- Collaborate with Software Engineering and cross-functional teams to identify, resolve, and verify design and software defects, supporting quality improvements and product lifecycle management.
Minimum Requirements
- Bachelor's degree in Computer Science, Biology, Biomedical Engineering, or related field.
- 3+ years of experience in Computer System Validation (CSV) and/or Product Software Validation in a regulated environment.
- Strong knowledge of FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, ISO standards, design controls, risk management, and software validation principles.
- On-site role based in Bengaluru (India).
Ideal Candidate Profile
- Experienced in planning and independently leading small to medium validation projects with minimal supervision.
- Hands-on expertise with Windows environments, web application testing, SQL query analysis, troubleshooting, defect management, and validation documentation development.
- Familiarity with regulatory inspections, quality audits, and transitioning from traditional CSV to Computer Software Assurance (CSA) methodologies is advantageous.