System Analyst & Validation Engineer

This position plays a pivotal role in managing and optimizing a multi-site Test Data Management System (TDMS) within a dynamic manufacturing and software development environment. The selected candidate will drive quality control, regulatory compliance, and digital transformation by acting as both Business Analyst and Tester, collaborating with cross-functional teams to enhance workflows and implement scalable solutions. Reporting directly to the manager of the TDMS application, this individual will ensure the integrity and efficiency of data management processes supporting manufacturing and labeling operations.

As a key contributor in a dynamic manufacturing and software development landscape, you will:

• Serve as the subject matter expert for a multi-site Test Data Management System (TDMS) (Specialized in house application) that serves as Lab Information Management Systems (LIMS) and Labeling Systems (Product Labels and Inserts supplied by the Manufacturer) that generates digital and paper-based materials.
• Configure, optimize, enhance and maintain the TDMS application to support quality control testing, printing, and the digital delivery of product materials, ensuring alignment with evolving manufacturing needs.
• Safeguard the integrity, traceability, and regulatory compliance of manufacturing data across all digital systems and workflows.
• Fulfill dual responsibilities as Business Analyst and Tester for TDMS, applying best practices in requirements gathering, analysis, and solution verification & validation.
• Collaborate cross-functionally with Manufacturing, Quality, Labeling, and IT teams to collect, analyze, and document both business and technical requirements, driving efficient digital transformation initiatives.
• Identify process inefficiencies and workflow /technology gaps, and champion the implementation of scalable, data-driven solutions to enhance operational performance.
• Translate manufacturing and quality objectives into actionable user stories, functional specifications, and comprehensive test cases for continuous system improvement.
• Design, execute, and document system, integration, and regression testing in a hybrid (Waterfall and Agile) development environment, ensuring robust software quality.
• Prepare and maintain essential Quality Engineering/Assurance documentation, supporting streamlined compliance in highly regulated industries.
• Develop and update work instructions, procedures, and user documentation to be compliant and to facilitate effective system adoption and knowledge transfer.
• Lead incident analysis (e.g., CAPA, QN), manage defect triage, and drive root cause investigations related to manufacturing test data and system behavior, fostering a culture of continuous improvement.
• Contribute to system enhancements, verification, validation (CSV) activities, and ongoing optimization initiatives leveraging modern software development methodologies.

• Bachelor's degree in Biology, Chemistry, Information Systems, Engineering, Computer Science, or equivalent professional experience.
• Demonstrated expertise with LIMS systems (like TDMS) as a Subject Matter Expert, Business Analyst, System Analyst, Developer or Test Engineer.
• Established background in Manufacturing Quality Control for assays, with a proven ability to manage and optimize test data and related processes.
• Practical, hands-on experience managing manufacturing test data, supporting manufacturing systems, or maintaining quality control systems in a regulated setting.
• Experience operating in highly regulated environments-preferably in manufacturing, healthcare, or life sciences-ensuring compliance and best practices.
• Proficient in validation documentation (IQ/OQ/PQ) and familiar with Computer System Validation (CSV) standards within regulated industries.
• Strong knowledge of the software development life cycle (SDLC), requirements management, and software testing methodologies within hybrid Waterfall and Agile environments.
• Exceptional communication skills, enabling effective collaboration with both technical and non-technical stakeholders across cross-functional teams.
• Advanced analytical, documentation, and problem-solving capabilities to support process improvements and sustain system excellence.

Nice to Have

• Hands-on experience with Application Life Cycle Management (ALM) tools, such as Microsoft ADS, to System development in regulated environments.
• Test Management in Microsoft ADS is a plus.
• Familiarity with leveraging AI tools to enhance process efficiency, data analysis, and operational excellence.
• Proven ability to work effectively within Agile or hybrid project methodologies, ensuring flexibility and compliance with industry standards.

401(k), Health insurance, Paid time off, Vision insurance, Dental insurance, Life insurance, Disability insurance, $95,770 - $131,681

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.