Computer System Validation Engineer

1 day ago

Chennai Tamil Nadu India Pharmatek Consulting Full time ₹ 12,00,000 - ₹ 24,00,000 per year

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: • Bachelor's degree in Computer Science, Pharmaceutical Science, Biochemistry, Chemistry, or related fields is required. • Master's 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

  • Csv (computer Systems Validation) Engineer

    1 week ago

    India Maneva Consulting Full time

    Greetings from Maneva Job Title -CSV Computer System Validation Engineer Experience - 5 - 10 Years Location - PAN India Hybrid Notice - Immediate to 15 days Requirement - Strong understanding of CSV Computer System Validation principles and lifecycle Experience with GxP systems and regulatory compliance e g 21 CFR Part 11 GxP Standards Basic understanding of...

  • Computer Technician

    4 days ago

    Chennai, Tamil Nadu, India Mediscan system Full time

    A Computer Technician's job is to ensure smooth functioning of computer systems and networks by installing, maintaining, and repairing hardware and software, providing technical support, and troubleshooting issues. They also play a role in onboarding new hires, training employees, and implementing security measures. Key Responsibilities: - **Hardware &...

  • Bluetooth Systems Validation Engineer

    4 weeks ago

    India Intel Full time

    Job Details Bluetooth System Validation Engineer - Debugs software products through the use of systematic tests to develop apply and maintain quality standards for company products Develops modifies and executes software test plans Analyzes and writes test standards and procedures Maintains documentation of test results to assist in debugging and...

  • Validation & Verification Engineer - BESS System

    2 weeks ago

    Chennai, India Hitachi Energy Full time

    Job Description The Opportunity To ensure the technical robustness, consistency, and compliance of Hitachi Energy's solutions by leading structured validation and verification processes that guarantee functional integrity, regulatory adherence, and high-quality system performance across diverse applications and architectures. How You'll Make An Impact - Lead...

  • Senior System Integration

    2 weeks ago

    Bengaluru, India Schneider Electric Full time

    Job Description Job Title: Senior System Integration & Validation Engineer Location: Bangalore, India Department: Digital Buildings Position Type: Full-Time / Contract Travel Required: No Position Overview: We are looking for a highly experienced Senior System Integration & Validation Engineer to lead large-scale system integration efforts and end-to-end...

  • QA Engineer

    3 weeks ago

    Bengaluru, India Capla GmbH Full time

    Job Description Company Description: At Capla, we are redefining the future of surgery through intelligent, connected, and data-driven medical technologies. Our mission is to make surgery smarter, safer, and more human-centered by combining the power of AI, machine learning, cloud computing, and advanced visualization systems. We are developing...

  • Computer system Validation

    4 weeks ago

    Ahmedabad, Gujarat, India, Gujarat Veeda Lifesciences Full time

    Primary Responsibility:• To provide support for Bioanalytical systems and users.• Actively support participation in System /Software validation activity and its execution.• Responsible for IT Server and System Backup and restoration process as defined in Sops, must have knowledge documenting the activity as per above mentioned.• Weekly ,Monthly...

  • HIL Validation Engineer

    5 days ago

    tamil nadu, India Themesoft Inc. Full time

    Greetings from Themesoft! We are seeking HIL Validation Engineers who are passionate about automotive systems, testing, and automation to join our client in Chennai location. Location: ChennaiExperience: 6+ years to 10 years Notice Period: Immediate joinersPosition: Contract Domain: Automotive Electronics / Electrical SystemsSkills Required:dSPACE, ECU Test...

  • [3 Days Left] Computer System Validation

    1 week ago

    Bengaluru, India People Prime Worldwide Full time

    Job Description About Company : They balance innovation with an open, friendly culture and the backing of a long-established parent company, known for its ethical reputation. We guide customers from what's now to what's next by unlocking the value of their data and applications to solve their digital challenges, achieving outcomes that benefit both business...

  • Computer Technician

    2 days ago

    Chromepet, Chennai, Tamil Nadu, India iFuture iVision System Full time

    computer science engineering DCE, BSC computer science Vision based automation solutions Vision Programming Engineer **Job Types**: Full-time, Fresher **Salary**: ₹9,926.35 - ₹17,932.45 per month **Benefits**: - Cell phone reimbursement Day range: - Monday to Friday Shift: - Day shift Ability to commute/relocate: - Chromepet, Chennai, Tamil...