4 Validation Engineering Jobs

Role Description: The V al idation and Testing Lead is responsible for leading the testing activities for software applications an d solutions that meet business needs and ensur ing the availability of critical systems and applications . This role is for a lead tester with experience testing data management solutions and data analytics products, and with experience with designing and executing testing for GxP validated systems . The role i nvolves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions . Roles & Responsibilities: Participate inrequirementdiscussionsin order to create test scripts. Build test scriptsper implementation project plan by working with various members of the product team and business partners. Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues Perform regression testing to verify the changes do not negatively impact existing system functionality Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Identify and resolve technical challenges/bugs effectively Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time Support the creating and implementation of automated testing frameworks to improve efficiency and consistency Basic Qualifications and Experience: Masters degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, IT or related field Diploma and 10 to 12 years of experience in Computer Science, IT or related field Functional Skills: Must-Have Skills: Knowledge of GxPsoftware validation processes Experience with test management in Jiraand test automation practices Expert sql skills for data profiling and creation of test data Strong experience testing analytics and data platforms Good Problem-solving skills - Identifying and fixing bugs, adapting to changes Excellent communication skills - Explaining design decisions, collaborating with teams Experienced in Agile methodology Good-to-Have Skills: Experience in Risk-based Approach to Change Management of Validated GxP Systems Experience with cloud-based technologies Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFE for Teams certification (Preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills

Manage the customer relationship in terms of Software (meetings, reports...), Project & Risk Management. Define and track the planning & Goals progress for the SW project.. Build a technical answer to Request for Quotation. Estimate SW Validation Testing effort. Expertise in HIL, ECU testing. Expertise in Solving Technical Problems. Hand on Experience on Field Bus: CAN, LIN and UDS. Hands on Experience on Vector tools (CANOE, CANDELA, CAVDIVA), CAPL, VT Studio, Conformance Test (LIN & CAN). Should have practical knowledge on Progr. Language (C, C++), Electronic: digital & analog. Hands on Experience on ASPICE process, Iterative & Incremental Life Cycle. Practical knowledge on SW Configuration, Change Management & Quality Assurance. Know- how on the concepts - build a software requirements specification, build a software architecture, build a software for delivery. Know-how on the concepts of Modular & object oriented* Design, Embedded SW & RTOS, Development Environment (emulator, cross compiler...) Should be able to solve Technical Problem. Should be from Automotive background with good communication skills.

What you will do Lets do this. Lets change the world. In this vital role you will support the implementation and operational management of real-world evidence platforms at Amgen, ensuring the integrity and compliance of critical systems and data. This role involves collaboration with various Amgen teams to enhance and secure real-world evidence operations. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality results from the team. Roles & Responsibilities: Develop detailed test plans and strategies based on project requirements and specifications. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects and issues identified during testing, and work with development teams to resolve them. Maintain detailed documentation of test/validation plans, test cases, and test results. Validate that test scenarios meet feature acceptance criteria and customer expectations. Maintain and ensure the quality of documented user stories/requirements in tools such as Jira. Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment. Prepare, execute, document, and report validation protocols in line with GxPs and other regulatory requirements and standards. Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations. Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 4 - 6 years of experience in Life Science/ Biotechnology/ Pharmacology/ Information Systems experience OR Bachelors degree with 6 - 8 years of experience in Life Science/ Biotechnology/ Pharmacology/ Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science/ Biotechnology/ Pharmacology/ Information Systems experience Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience with validation solutions, including compliance and data integrity. Good-to-Have Skills: Familiarity with cloud platforms (AWS / Databricks) and GCP regulations. Experience with validation solutions, including compliance and data integrity. Able to communicate technical or complex subject matters in business terms Jira Align experience Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision. Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams, High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

What you will do Lets do this. Lets change the world. In this vital role you will be working closely with Business collaborators, Product Owner, Business Analysts, Developers, and Testers to ensure that Validation strategy and work are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also demonstrates domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications. Develop and manage test cases, protocols, and validation documentation within the Veeva VM Testing Vault. Implement test scripts to ensure system compliance with regulatory requirements and organizational standards. Identify, document, and track defects during the testing process. Collaborate with development teams to resolve defects and validate fixes. Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the VM Testing Vault to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and customers to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and standard processes. Offer ongoing support to ensure effective use of the platform. Generate reports and dashboards to monitor testing progress, defect trends, and validation status. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications and Experience: Masters degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT or related field. Functional Skills: Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. Good-to-Have Skills: Proficiency in automation tools and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management). Experience of DevOps, Continuous Integration and Continuous Delivery methodology. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies. Professional Certifications: SAFe for Teams certification (preferred) Veeva VM certification (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours.