3 Validation Engineer Jobs

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.

The Validation Engineer is responsible for planning and executing the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a senior 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 involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions. Roles & Responsibilities: Participate in requirement discussions in order to create test scripts. Build test scripts per 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Masters degree with 1 to 3 years of experience in Computer Science, IT or related field OR Bachelors degree with 3 to 5 years of experience in Computer Science, IT or related field Must-Have Skills: 3 years experience in a testing role Knowledge of GxP software validation processes Experience with test management in Jira and 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: 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

Role & responsibilities Electronic Hardware, Principal Test & Validation Engineer(Job Number:009BZ7) Description As a power electronics engineer with at least 5 years of design experience, you will be responsible for: Manage PEP (Product Evolution Process) topics, considering our design rules Managing product maintenance and evolution topics (Quality, Obsolescence, Adaptation, QVE) Investigating to identify the root causes of design issue, then to find a solution to deal with it. Selection and dimensioning of active and passive components, and justification of the design. Creating electrical schematics and overseeing PCBA design in collaboration with the PCB team. Conducting design tests on prototypes, debugging for compliance. Performing verification tests and debugging the boards. Supporting the validation team during the testing phase. Providing internal advice and knowledge sharing, helping with decision-making in technical topics Mastering technical specifications, ensuring knowledge and know-how capitalization, staying updated on technological developments. Accelerating our digital transformation with 3D simulation tools. Qualifications Solid and proven knowledge in electronics (Power, Analog and digital) Solid and proven knowledge in power conversion and static converter topologies. Ability to work independently on the power conversion part of a drive, from concept to qualification phase (defining architecture, loss calculations, simulations, component specification according to standards, supplier relations, component qualification). Experience in magnetic component design for power (inductors/transformers). Understanding of EMC phenomena and mitigation solutions. Open-mindedness, analytical thinking, flexibility, and the ability to act independently and take responsibility. Good organizational skills and ability to manage multiple tasks simultaneously. Strong knowledge of simulation tools (Matlab/Simulink, PLECS, Spice). Proficiency in 3D simulation tools (Maxwell, CST, Flotherm, 6SigmaET) is a plus. Ability to work in multidisciplinary and multicultural teams with diverse nationalities. Occasional travel within France and abroad may be required. Proficiency in English is essential, French language skills are a plus. Preferred candidate profile Perks and benefits