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LS Solutions, Inc. provides resourcing and technology solutions for life sciences and healthcare clients across all locations globally. LS Solutions, Inc. is seeking Software Validation Engineer(s) for its office in Princeton, New Jersey. The individual will apply advanced theoretical knowledge and practical experience of computer science/engineering/information technology principles and concepts, experience using standard occupational tools, as well as knowledge of the government regulated environment to perform the following duties and responsibilities: 1. Develop validation plans to ensure compliance with FDA regulations and company policies for IT systems. 2. Analyze requirements and develop test cases using IT, compliance, and engineering knowledge. 3. Perform IT validation activities for pharmaceutical/medical devices systems in different computing environments. 4. Understand client validation procedures and requirements for new or modified processes and systems supporting manufacturing. 5. Lead planning for validation testing activities, including OQ, PQ, and pre-validation UAT protocols. 6. Develop test strategy and plan for operational and performance protocols. 7. Execute validation test protocols and document test results. 8. Develop defect reports, track their resolution, maintain Requirements Traceability Matrix (RTM), and prepare Test Summary Report summarizing all test activities and open deviations. 9. Track and monitor review and approval of validation deliverables. 10. Participate in meetings with project team and client stakeholders as needed. 11. Develop user requirements, system requirements, system flow diagrams, specifications, configurations, and design specifications. 12. Participate in internal or external training programs to stay updated on validation principles. 13. Use HP Quality Center for tracking validation activities, test results, and test defects. 14. Conduct audits of validation and performance qualification processes to ensure compliance with internal and regulatory requirements. THIS POSITION DOES NOT SUPERVISE OTHER PERSONNELMinimum requirements: Master’s degree in Computer Science, Engineering (any field), Information Technology, Information Systems, Management Information Systems, Technology Management or related field of study, and 6-months of experience in job offered or related position(s) in which the required experience was gained. Qualified applicants must also have demonstrable proficiency and knowledge with the following: 1. FDA guidance and pharmaceutical industry standards including GAMP and regulations including predicate rules, Electronic Record Electronic Signatures and Quality System Regulations. 2. Life sciences standards and drug development process. 3. Validation software including two or more of the following: Documentum, Enterprise Resource Planning (ERP), Learning Management, Laboratory Information Management System (LIMS), Clinical Trial Management System, or Safety Management System, Liquent Insight Publisher, Core Dossier using risk-based validation approach. No travel. No telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of the project.Additional Information:•Job Site: 731 Alexander Road, Ste. 101, Princeton, NJ 08540•Salary: $91,811 per year.•Corp benefits offered: PTO, dental, vision, med/RX, 401(k).•Email resumes to hr@ls-sol.com & reference job title•No calls. EOE.•Must be legally authorized to work in the United States without sponsorship.#LI-DNI