Validation Engineering I Amgen Technology Private Limited

1.0 - 9.0 years

1 - 9 Lacs

Hyderabad, Telangana, India

On-site

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Key Deliverables: Develop and maintain validation plans and lifecycle documentation Execute risk-based validation for regulated systems and applications Support change control and continuous validation activities Ensure compliance with GxP, 21 CFR Part 11, and Annex 11 requirements Role Responsibilities: Collaborate with product, design, and QA teams to ensure software readiness Conduct requirement analysis and author validation artifacts Monitor system performance and support incident resolution Maintain validation frameworks aligned with Amgen SOPs and regulatory trends

Posted 1 day ago

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Mechanical Engineer Interior Integration Alstom

5.0 - 7.0 years

5 - 7 Lacs

Bengaluru / Bangalore, Karnataka, India

On-site

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Supporting Interior & CAB domain activities and deliverables on a project in compliance with QCD commitments. Implementing applicable Train Design Metier instructions, processes & tools. Organisation Reporting Hierarchical Reporting: (Site) Domain Lead (DL) Functional Reporting: (project) Mechanical Lead Engineer (MLE) Accountable for : Planning and piloting Interior & CAB Domain activities and related deliverables on project considering applicable instructions/processes and other specific Customer (internal or external) requirements. Ensuring Interior & CAB Domain deliverables quality and their acceptance by the Customer (internal or external) within committed limits. Reporting activities progress and alerting relevant N+1 in case of issue potentially impacting achievement of QCD commitments. Coordinate with internal / external customer/ supplier (local or global) to validate inputs to ensure QCD targets on first time. Defining requirements and mechanical interfaces of equipment (Allocated volume, weight, location, preferred part list etc.) Demonstrate standard engineering practices (example: material selection, Tolerance stack up, Location strategy, perceived quality, knowledge of manufacturing, serviceability, assembly, LCC, DFMEA) during design phase Writing system specifications derived from train level requirements; validating MOP through test specifications and reports. Monitoring assigned Mechanical Sub-Systems deliveries conformity with project needs. Checking supplier's and sub-contractor's Design Quality. Responsible for: Implementing Train Design rules, processes and tools (single-domain) and ensuring Interior & CAB Domain deliverables quality and their acceptance by the Customer (internal or external) within committed limits Participating in production of deliverables in accordance with planning targets on Mechanical Domain assigned work-packages. Designing products considering project requirements (performances, manufacturability, serviceability, testability, etc.). Preparing and documenting Mechanical Domain Design Reviews according to project schedule and following-up the main open actions. Checking respect of Allocated volumes/interfaces (no-clashes) on internal design. Reporting on Mechanical Domain activities progress, anticipating issues (capacity, skills, rule applicability, etc.) and alerting if needed. Respecting and/or allocating requirements and mechanical interfaces to Sub-Systems/equipment (Allocated volume, weight, location, Project specific part list, etc.) Analysing and consolidating change request impacts on domain scope Producing Domain deliverables (Requirement management in DOORs tool, Validation Plan, design deliveries, design reviews, Co-engineering with cross functional teams etc.) Validating relevant Mechanical Domain deliverables and securing planning. Verifying design via mock-ups or simulations. Contributor for : Supporting Sourcing, Industrialization and Manufacturing teams during Production ramp-up. Collaborating with MDL for continuous improvement of the Domain (including RoE) Establishing Certification & Validation Plans for TD scope. Knowledge & Experience Mechanical Engineering graduate preferably experienced in Railway products with 5 to 7 years of strong design exposure. Knowledge of basic product design life cycle and engineering rigor to achieve first time right. Good Communications and interpersonal skills including with third parties (customer). Time management and reporting skill. Customer & Product Focus. Sound technical background with knowledge of RS commodities preferred Structured and organised with Hands-on approach. English operational in read/writing and technical meetings. Knowledge of Foreign language (ex. French, German. etc) shall be favourable.

Posted 2 weeks ago

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