3 Validation Protocols Jobs

ABOUT THE ROLE Role Description: We seek a skilled Sr. Associate Validation Analyst to oversee and manage validation activities for AI platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the AI products follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles Responsibilities: Plan, coordinate, and lead the execution of validation and change control activities, including qualification and validation of AI products and platforms. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Functional Skills: Must-Have Skills: 5 or more years of experience in validation in a GXP-regulated environment (pharmaceutical, biotech, medical devices, etc. ). Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Education and Professional Certifications Master s degree and 2 years of Information Systems experience, OR Bachelor s degree and 4 years of Information Systems experience 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. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. .

What you will do Role Description: We are seeking a highly skilled Validation Engineer to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Develop and maintain Validation Plans, including scope, responsibilities, deliverables, and timelines. Perform risk-based assessments to determine the level of validation required. Assist in defining User Requirements and Functional Requirements. Draft and review various validation artifacts. Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations. Coordinate and/or execute validation protocols. Support change management processes for validated systems. Ensure continuous validation throughout the system lifecycle (including periodic reviews). Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time. Stay updated with the latest trends and technologies, and related fields. Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently. Basic Qualifications: Masters degree and 1 to 3 years of experience in Computer Science, IT or related field experience OR Bachelors degree and 3 to 5 years of experience in Computer Science, IT or related field experience OR Diploma and 7 to 9 years of experience in Computer Science, IT or related field experience Must-Have Skills: Strong technical background, including understanding software development processes, databases, and cloud-based systems. Experience implementing CSA guidance. Experience with product backlog management (e.g., Jira) and collaboration tools. Preferred Qualifications: Basic understanding of Veeva Quality Vault. Strong Analysis skills with basic Veeva configuration knowledge. Excellent communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and problem-solving 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.

Description We are seeking a highly skilled and experienced V&V Vehicle System Test Lead Engineer to join our team in India. In this role, you will be responsible for leading the verification and validation activities for AD/ADAS technologies, ensuring the highest standards of quality and performance in our vehicle systems. Responsibilities Lead the verification and validation (V&V) activities for vehicle systems focusing on Advanced Driver Assistance Systems (ADAS) and Automated Driving (AD). Develop and execute test plans, procedures, and reports for both hardware and software components of vehicle systems. Collaborate with cross-functional teams including software developers, hardware engineers, and system architects to ensure seamless integration of AD/ADAS technologies. Identify and mitigate risks associated with V&V processes while ensuring compliance with industry standards and regulations. Analyze test results, diagnose issues, and provide actionable insights to improve system performance and reliability. Mentor junior engineers and provide guidance on best practices in V&V processes for vehicle systems. Skills and Qualifications Bachelor's or Master's degree in Engineering (Electrical, Electronics, Mechanical, or a related field). 7-12 years of experience in V&V, testing, or related roles within the automotive industry, specifically with AD/ADAS technologies. Strong understanding of vehicle systems architecture and AD/ADAS functionalities. Proficient in using testing tools and simulation environments (e.g., MATLAB, Simulink, CANoe, etc.). Experience in developing automated testing frameworks and methodologies for vehicle systems. Knowledge of automotive standards and regulations (ISO 26262, ASPICE, etc.) is a plus. Excellent analytical and problem-solving skills with a keen attention to detail.