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Computer System Validation Engineer Chennai, India Indian Time shift (Some overlap to US time) Key Responsibilities Requirements Gathering & Analysis: Collaborate with IT, Quality, and business stakeholders to elicit, analyze, translate, and document business requirements into functional and technical specifications.Preparation and Execution of Validation Deliverables as per GAMP5 and 21 CFR Part 11 requirements.Perform validation activities of Computerized Systems in the Life Sciences/Pharma Industry.System Implementation & Support: Work with business users to configure systems, resolve bugs, and implement enhancements.SOP Development: Draft and update SOPs, templates, and operational documentation to align with regulatory standards.System Administration: Manage user access provisioning, security roles, and configuration management for supported systems.Stakeholder Engagement: Partner with global teams to ensure timely project delivery, meeting regulatory compliance standards (e.g., CFR Part 11).Training & Manuals: Develop user manuals and provide training to ensure effective system usage by the business community. Requirements Minimum 3 years in IT and/or R&D and Quality operations within the biotech or life sciences industry. 5+ years of experience implementing solutions for quality, clinical operations, and regulatory affairs.Hands-on experience with Veeva Vault, Benchling, or similar platforms is required.Knowledge of clinical trial management, regulatory operations, and Computer Systems Validation (CSV).Familiarity with Software Development Life Cycle (SDLC) policies in regulated environments.Education:Bachelors degree in Computer Science, Pharmaceutical Science, Biochemistry, Chemistry, or related fields is required.Masters degree preferred. Technical Skills: Demonstrated expertise in writing software requirements, test specifications, and validation protocols.Proficiency in managing global/regional projects with cross-functional teams.Certifications (Preferred):Training in Clinical Trial Management, Regulatory Operations, and CFR Part 11.CBAP or ISTQB Certifications Skills: veeva,validation & testing, stakeholder engagement, validation, system administration, software development life cycle, computer systems validation, cfr,computerized system validation (csv), requirements gathering, benchling, documentation, clinical trial management, life sciences, regulatory operations, sop development, veeva vault, training & manuals, system implementation & support .
Here's how to pick the right one and stand out in your application.
144.883Jobs
31.687IN
81%EN
That number is real. WorkMundi's database shows 144,883 open engineer roles across the world. India has the most with 31,687 jobs, followed by the United States with 30,084. If you just finished reading one job ad and felt paralyzed by choice, you're not alone—but this scale is actually an advantage. It means you can afford to be selective.
Start by geography and language. The majority of engineer ads—117,837 of them—have the job posting text written in English. Use that as one filter, but remember: the ad text language tells you nothing about whether the role actually requires you to speak English day-to-day. Read the job description carefully. Then check which countries have the volume you're targeting. Singapore, Poland, and Australia round out the top five after India and the US.
Next, learn who's hiring. Accenture has posted 2,801 engineer roles. andurilindustries, speechify, and jobgether are also actively recruiting. If you're applying to one of these names, research their hiring patterns and interview style before you apply. That homework pays off.
When you interview, expect the question every engineer hears: 'Tell me about a time you had to debug a problem that wasn't in your job description.' Have a specific story ready—not a general one. Name the tools, the deadline pressure, and what you learned. Hiring managers listen for whether you see problem-solving as part of the role itself, not a favour.