System Analyst & Validation Engineer

Role Overview 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. Responsibilities Serve as the subject matter expert for a multi‑site TDMS that functions as Lab Information Management Systems (LIMS) and labeling systems for product labels and inserts supplied by the manufacturer, generating 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. Your Expertise 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, for 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. Base Pay Level $79,800 – $109,725 Benefits 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 Equal Employment Opportunity Statement Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, we will provide the necessary support. EEO is the Law Applicants and employees are protected under federal law from discrimination. The company complies fully with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations. #J-18808-Ljbffr