2 Validation Software Jobs

Responsibility for planning, coordinating, and executing testing for air compressors according to SE standards and international standards (ASME PTC-10 & VDI 2045). You should have a basic knowledge of electrical and instrumentation, validation software/codes, and a proven understanding of testing data. Additionally, you should possess knowledge of testing scope, recommend instrumentation to meet requirements, perform data acquisition during testing, set up mechanical, electrical & instrumentation items, and acquire corresponding data. You will make an impact by collecting test data throughout the test operation, preparing a test procedure for air compressors, evaluating test data, preparing a test report, demonstrating experience in rotating equipment testing, having proficient knowledge of diverse measurement techniques and data acquisition systems, understanding the operation of rotating equipment and balance of plant items for air compressors, and having programming knowledge and experience in working with testing data. You will be responsible for developing, reviewing, testing, qualifying, and approving Inspection Test Plans for IGC (GC/GV), as well as developing, reviewing, testing, and qualifying IGC (GC/GV) assembly/testing procedures as per SE standard, client/code requirements. You will also need to coordinate with SE-Germany for any queries or clarifications needed during project execution and demonstrate process control during assembly & testing. Reading Compressor & Package Engineering drawings, keeping them up to date, optimizing testing processes, planning for strategic improvements, and improving company profitability are also part of your responsibilities. Working with the manufacturing services team to develop regular maintenance and inspections on equipment and materials, ensuring compliance of IMS in the respective work area, driving RCA investigation of Quality incidents related to IGC testing, providing client Quality assurance for products and services, and assisting in assuring the achievement of optimum Quality costs are essential tasks. To be successful in this role, you should have a Bachelor's degree in mechanical or production engineering, along with 10-15 years of experience in a Quality Control/Assurance Engineer or Testing Engineer position within a technology organization, preferably with similar IGC product experience. You should have experience in preparing and verifying IGC test procedures, assembly records, and test checklists. Good organization skills, including time management, detailed reporting, systematic record-keeping, and report writing, are required. Systematic interpersonal skills, advanced English skills, the ability to understand and define client needs, and the flexibility to work in a schedule that meets business needs are also necessary. Demonstrating excellent interpersonal skills, attention to detail, proficiency in using Microsoft Office Suite, coordinating and collaborating with teams from different departments for process development activities, and the ability to travel as required are important attributes. Knowledge of Lean manufacturing methodologies and strong decision-making abilities are also valuable qualities. The Transformation of Industry division at Siemens Energy is focused on decarbonizing the industrial sector, increasing electrification and efficiency, and meeting the rising demand for green H2 and derivative fuels. The division enables the decarbonization of the industrial sector and the transition to sustainable processes, leveraging a strong industrial customer base, a global network, diverse technologies, and integrated execution capabilities. Siemens Energy is a leading energy technology company that meets the energy demand across 90+ countries while ensuring climate protection. With more than 98,000 dedicated employees, Siemens Energy generates electricity for over 16% of the global community and uses technology to help protect people and the environment. The distributed team at Siemens Energy is committed to making sustainable, reliable, and affordable energy a reality by pushing the boundaries of what is possible and upholding a 150-year legacy of innovation. Siemens Energy seeks individuals who will support the focus on decarbonization, new technologies, and energy transformation. Siemens Energy values diversity and inclusion, recognizing that through diversity, power is generated. With over 130 nationalities represented, Siemens Energy celebrates character regardless of ethnic background, gender, age, religion, identity, or disability. The company energizes society without discrimination based on differences. Employee benefits at Siemens Energy include remote working arrangements up to 2 days per week, automatic coverage under Medical Insurance, considerable family floater cover, an option to opt for a Meal Card, and tax-saving measures as part of the CTC package.,

Let's do this. Let's change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. 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 leverages 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: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Identify opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict adherence to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms. What we expect of you: We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master's degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor's degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Industry 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 in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11 Proficiency in automation tools, data systems, and validation software Preferred Qualifications: Experience in Clinical Trial Registry and Regulatory submission publishing systems and processes Knowledge of the Disclose application from Citeline and docuBridge from Lorenz Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams 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