27 Validation Plans Jobs

Responsible for implementation, and effectiveness of Validation strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, compliance related activities (ICH, 21 CFR, GPDR etc), and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 r...

Role: Electrical Design Quality Assurance Engineer Employment Type: Full Time Educational Qualification: BE/BTech in Electrical/Electronics Engineering Work Experience: 3-5 years of experience in Design QA, Electrical QA, Testing, or Validation roles. Role Description We're looking for a proactive Electrical Design QA Engineer to ensure design robustness and compliance from concept to qualification through reviews, risk assessments, and verification planningpartnering with R&D, Production, and Validation to meet performance and reliability standards. Responsibilities & Duties Drive Design Quality Assurance activities throughout the design lifecycle, from concept, design validation, to produc...

As a Battery System Design Engineer, you will be responsible for designing systems for battery protection, charging, and gauging. You will develop engineering requirements specifications, test and validation plans for manufacturing and characterizing battery packs. Additionally, you will test batteries at the module level and at the system level to ensure optimal performance. Key Responsibilities: - Support prototype and engineering builds - Collaborate with cross-functional partners to integrate the battery into the final system - Work with vendors to develop custom and semi-custom ICs for battery management - Collaborate with the mechanical engineering team to develop battery modules and p...

As an EV Expert with experience in 400V BMS, Charging Systems, and Battery Pack, your role will involve the following key responsibilities: Role Overview: You will be responsible for BMS architecture and system design, EV battery charging system design, and EV battery pack engineering. Key Responsibilities: - BMS Architecture and System Design: - Understanding and applying BMS software - Integrating BMS in Battery Pack & ePWT System - Developing BMS algorithms and conducting functional validation - Validating BMS on HIL System - Conducting hands-on experience in 400V BMS functional validation and testing - Applying experience with Electric Vehicle BMS applications and relevant automotive sta...

Senior Validation QC Analyst - Bangalore/Chennai, India ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Principal Clinical Validation Analyst to join our diverse and dynamic team. As a Principal Clinical Validation Analyst at ICON, you will play a pivotal role in leading the validation processes for clinical data systems and software, ensuring compliance with regulatory standards and the highest levels of data integrity. You will work closely with cross-func...

Job Description : Work Schedule Second Shift (Afternoons) Environmental Conditions Office The Associate Validation Analyst is responsible for providing basic business/system support for software systems and validated systems. Collaborate with various departments and clients to initiate and complete performance qualification (PQ) validation activities. Facilitate the validation process, system upgrades, and ongoing support of software systems. Essential Functions: Participates as a member of project teams where needed, contribute to system enhancements, review change requests, and ensure effective communication and testing accuracy. Provide validation support for new releases and modification...

Role Overview: As a Systems Engineer, your role will involve utilizing your knowledge of systems engineering and understanding of vehicle architecture. You will be responsible for writing specifications and validation plans, as well as reading and comprehending specifications to ensure the successful execution of projects. Key Responsibilities: - Gather, analyze, and document system requirements as part of Requirement Engineering. - Create system architectures considering factors such as performance, cost, and reliability in Architecture Design. - Develop test plans for system functionality and performance verification in Validation Planning. - Investigate and resolve technical issues that m...

As a CPU Validation Engineer at Qualcomm India Private Limited, you will be responsible for validating next-generation CPU designs on Emulation and Post Silicon platforms. You will collaborate closely with design, verification, and software teams to ensure the CPU meets functionality and performance requirements. Your role will involve developing and executing validation plans for CPU features and architecture, performing post-silicon validation and bring-up of CPU cores, running validation test content to qualify feature functionality, identifying bugs, analyzing execution data and performance metrics to optimize validation efficiency, debugging and isolating system/platform issues, and col...

As a Lead Testing Engineer at Wabtec Corporation, you will be responsible for overseeing the testing and validation of electromechanical components, including relays, contactors, MCBs, and other low-voltage switchgear. Your role will involve developing comprehensive testing and validation plans, executing tests, analyzing results, and collaborating with cross-functional teams to ensure seamless integration of testing requirements. Additionally, you will stay updated with industry standards and regulations, mentor junior testing engineers, and provide detailed reports and recommendations to management. **Responsibilities:** - Experience in verification and Validation of Low voltage switchgear...

Job Description : Work Schedule Standard (Mon-Fri) Environmental Conditions Office Purpose: Provide basic business/system support for software systems and laboratory instrumentation. Collaborate with various departments and clients to initiate and complete performance qualification (PQ) validation activities. Facilitate the validation process, system upgrades, and ongoing support of software systems. Essential Functions: Participate in project teams, contribute to system enhancements, review change requests, and ensure effective communication and testing accuracy. Provide validation support for new releases and modifications throughout the software development life cycle. Prepare validation ...

As a leading company in the semiconductor industry, committed to innovation and excellence in engineering solutions, we are currently seeking a dedicated individual for the role involving working with fluid transfer systems and integrating systems with controls, with a focus on system-level P&ID creation. **Responsibilities:** - Proficiency in fluid transfer systems (pneumatics & hydraulics). - System integration of electromechanical with controls. - Expertise in system level P&ID creation. - Design of fluid systems and OEM component selection (pumps, actuators, valves, transducers, pressure regulators, sensors, gauges, etc.). - Performing hand calculations to ensure proper functionality, li...

Role: Electrical Design Quality Assurance Engineer Employment Type: Full Time Educational Qualification: BE/BTech in Electrical/Electronics Engineering Work Experience: 3-5 years of experience in Design QA, Electrical QA, Testing, or Validation roles. Role Description: We're looking for a proactive Electrical Design QA Engineer to ensure design robustness and compliance from concept to qualification through reviews, risk assessments, and verification planningpartnering with R&D, Production, and Validation to meet performance and reliability standards. Responsibilities & Duties: Drive Design Quality Assurance activities throughout the design lifecycle, from concept, design validation, to prod...

Role Overview: As a Principal Service Operations Engineer, you will play a crucial role in guiding the transition of PACS imaging systems and enterprise PACS migration. Your expertise in DICOM standards and imaging workflows will be utilized to ensure a seamless transfer of imaging data with minimal downtime, reliable access for radiologists, and physicists. Key Responsibilities: - Develop solutions architecture for migration across multiple legacy systems into the new PACS platform. - Collaborate with PACS vendors and internal teams to design and validate migration strategy, including data mapping, conversion, and testing. - Ensure adherence to DICOM, HL7, and IHE standards for interoperabi...

As a Mechanical Engineer in this role, you will be responsible for equipment sizing, specification, material requisition, and analysis of various mechanical packages including Gas Compressors, vessels, tanks, GSU, GDU, N2 Gen, Hold up Compressors, Air Compressor and Dryers, Chillers, Pumps, Air Coolers, Heat Exchangers, and more. You will develop and implement detailed mechanical designs for equipment, piping, and systems while ensuring adherence to relevant codes and standards. Conducting thermal and mechanical modeling and testing of packages to meet design requirements will also be a key part of your responsibilities. - Perform stress analysis, finite element analysis, and other engineeri...

What you will do: Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira). Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups Develop and execute validation strategies and plans for new and existing computerized systems. Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessment; Validation Plans (VP) ; IQ/OQ/PQ Protocols and Reports; Traceabil...

As an experienced candidate with 5+ years of relevant experience, your role will involve designing systems for battery protection, charging, and gauging. You will be responsible for developing engineering requirements specifications, test, and validation plans for manufacturing and characterizing battery packs. Your key responsibilities will include: - Testing batteries at the module and system levels - Supporting prototype and engineering builds - Collaborating with cross-functional partners to integrate the battery into the final system - Working with vendors to develop custom and semi-custom ICs for battery management - Collaborating with the mechanical engineering team to develop battery...

Our client, a global healthcare company, iseeks a SAP Validation Consultant, which involves ensuring the compliance, validation, and verification of SAP systems and processes to meet regulatory standards in the healthcare industry. The consultant will collaborate with internal stakeholders to ensure the SAP environment is compliant with industry-specific regulations, providing validation support during system changes, implementations, and upgrades. This is a remote, contract role, starting with a one-year contract for a 2 year project, that is likely to renew. The selected candidate can be located anywhere in India and must be able to support the client's EST preferred time. Key Responsibili...

Job Description GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 46 years Role Overview We are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory requirements, including 21 CFR Part 11 and EU Annex 11 . The specialist will lead Computer System Validation (CSV)/Computer Software Assurance (CSA) activities, manage compliance documentation, and provide expertise in pharma quality systems. This role will play a key part in enabling compliant deployment of advanced digital solutions. Key Responsibilities Lead ...

Role Overview: As a Systems Engineer, your role involves having knowledge of systems engineering and a general understanding of vehicle architecture. Your experience in writing specifications and validation plans, along with the ability to read and comprehend specifications, will be key to your success in this position. Key Responsibilities: - Gather, analyze, and document system requirements as part of Requirement Engineering. - Create system architectures considering factors such as performance, cost, and reliability in Architecture Design. - Develop test plans to verify system functionality and performance in Validation Planning. - Investigate and resolve technical issues that may arise i...

Role Overview: As a Systems Engineer, you will be required to have knowledge of systems engineering and a general understanding of vehicle architecture. Your role will involve utilizing your experience in writing specifications and validation plans, as well as effectively comprehending specifications to meet the project objectives. Key Responsibilities: - Gather, analyze, and document system requirements through Requirement Engineering. - Create system architectures taking into consideration factors like performance, cost, and reliability in Architecture Design. - Develop test plans for Validation Planning to verify system functionality and performance. - Investigate and resolve technical is...

Responsible for implementation, and effectiveness of Validation strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives. Summary: Plans, coordinates and directs activities concerned with DDi QMS, compliance related activities (ICH, 21 CFR, GPDR etc), and regulatory compliance of processes and products. Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards. Accountabilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 r...

You are an EV Expert with experience in 400V BMS, Charging Systems, and Battery Pack for locations in Chennai, Bangalore, and Pune. You should have a qualification of B.Tech./M.E./MTech. in Electrical/Electronics. If you meet these criteria and are interested, please share your profile to careers@bluebinaries.com. The preferred notice period ranges from immediate to 60 days. Your responsibilities will include the following: 1. BMS Architecture and System Design (7 to 10 years experience): - Understanding and application of BMS Software - Integration of BMS in Battery Pack & ePWT System - Development of BMS Algorithms and Functional Validation - Validation of BMS on HIL System - Hands-on expe...

You should have a Bachelor's degree in Mechanical Engineering, Automotive Engineering, or a Master's degree in Mechatronics with 4 to 6 years of experience in the field. As part of your role, you will be responsible for designing, developing, and validating steering systems for heavy commercial vehicles (HCVs). Your key qualifications should include a strong understanding of Hydraulic and Electric Power Steering (EPS) systems and components, experience in preparation and validation of specifications, proficiency in 3D/2D CAD tools such as CATIA, and hands-on experience in Casting/Forging manufacturing design. Additionally, you should have experience with tolerance stack-up analysis, DFMEA, v...

You should possess a Bachelor's degree in Mechanical Engineering, Automotive Engineering, or M-Tech in Mechatronics with 4 to 6 years of experience. As a member of our team, you will be responsible for the design, development, and validation of steering systems for heavy commercial vehicles (HCVs). Your role will require a strong understanding of Hydraulic and Electric Power Steering (EPS) systems and their components, such as torque sensors, actuators, and steering columns. You should have experience in preparing and validating specifications and be proficient in 3D/2D CAD tools like CATIA. Hands-on experience in Casting/Forging manufacturing design, tolerance stack-up analysis, and DFMEA i...

As an experienced professional with over 3 years of experience in Computer System Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, or medical devices, you will be responsible for developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. Conducting risk assessments and gap analyses will be a key part of your role to identify potential quality issues and implement necessary corrective actions. Your responsibilities will also include developing and maintaining quality documentation, such as Standard Operating Procedures (SOPs), validation plans, test cases, a...