LS Solutions, Inc. in Princeton, NJ is seeking Senior Software Validation Engineer(s) to analyze science, engineering, business, and other data processing problems to develop and implement solutions to complex applications problems, system administration issues, or network concerns. 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 new standard operating procedures (SOPS) for the business process and train the business users on new SOPs.2)Review and coordinate change tickets related to lab systems following client change control process.3)Provide training and mentorship of junior team members.4)Serve as site expert in the validation of computer and software systems used in quality processes as per GAMP5 guideline and FDA regulations including 21 CFR Part 11 that includes maintaining electronic signatures, electronic records, data integrity, and security.5)Serve as a Subject Matter Expert in Audit discussions by the FDA and other certifying groups related to Validation of processes, equipment, and/or systems. Provide the required Validation Documentation Package/Binder and change controls related to it for the auditors.6)Review and approve the drug product(s) formula card processes/ instructions.7)Author process validation protocols and summary reports for the approved drug formula process and submit final reports for manufacturing processes used in the quality process.8)Perform cleaning/sanitization validation for the sanitization process of compounding equipment-tank, pump, hoses, product line & filler, and CIP tanks.9)Coordinate resources and communicate project progress, apply project management tools and techniques effectively for multiple projects.10)Provide technical assistance and interface with other departments in connection with validation requirements.11)Verify the equipment/system identification, P&IDs electrical drawings, piping drawings, purchase specifications, operating manuals, and other necessary documentation.This position does not supervise any personnel or participate in any management decisions, nor does this position plan, direct or coordinate the activities of any personnel.Minimum requirements: Master’s degree in Computer Science, Engineering (any field), Information Technology, Information Systems, Management Information Systems, Technology Management or related field of study, plus at least three (3) years of experience in the job offered or in any related position(s).Qualified applicants must also have demonstrable proficiency and knowledge with the following:1. Three or more validation procedures and laboratory/manufacturing equipment and processes: chromatography systems, stability system, empower, soft Maxpro, incubators, spectrophotometers, plate readers, or autoclaves.2. Lead the planning for all validation testing activities (OQ, PQ and pre-validation UAT protocols) for stability system or lab systems.3. FDA guidance4. Pharmaceutical industry standards including GAMP5. Pharmaceutical regulations6. Life sciences standardsNo 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•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