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LS Solutions, Inc. in Princeton, NJ is seeking Senior Validation Engineer(s) III to analyze science, engineering, business, and other data processing problems to develop and implement solutions to complex apps problems, system admin issues, or network concerns.The individual will apply advanced theoretical knowledge & 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) Support validation activities for pharmaceutical systems and equipment across multiple computing environments.2) Understand the client validation procedures and requirements in validating new or modified processes & systems that supports laboratories in pharmaceutical industry.3) Conduct audits of validation & performance qualification processes to ensure compliance with internal or regulatory requirements.4) Develop new Standard Operating Procedures (SOPS) for the business process and train the business users on new SOPs.5) Review and coordinate change tickets related to lab systems following client change control process.6) 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.7) Review and approve the drug product(s) formula card processes/instructions.8) 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.9) Perform cleaning/sanitization validation for the sanitization process of compounding equipment-tank, pump, hoses, product line and filler, and CIP tanks.10) Coordinate resources and communicate project progress, apply project management tools and techniques effectively for multiple projects.11) Verify the equipment/system identification, P&IDs electrical drawings, piping drawings, purchase specifications, operating manuals, & 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 two (2) years of experience in the job offered or in any related position(s) providing the required experience.In lieu of the above-stated primary education & experience requirements, employer will accept a Bachelor’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 five (5) yrs of post-degree, progressively responsible experience in any related position(s) providing the required experience.Qualified applicants must also have demonstrable proficiency & knowledge with the following:1. 3 or more validation procedures and laboratory/manufacturing equipment & processes: chromatography systems, stability system, empower, soft Maxpro, incubators, spectrophotometers, plate readers, or autoclaves.2. Validation testing activities (OQ, PQ and pre-validation UAT protocols) for stability systems or lab systems.3. FDA guidance4. Pharmaceutical industry standards (GAMP)5. Pharmaceutical regulations and systems6. Life sciences standards7. Quality Management (Veeva, Trackwire)8. Automated/electronic testing tools (ACM, Qtest) in pharmaceutical laboratories or manufacturing plant.8. Project management tools/techniques (Jira, Sharepoint, or ITS project)No travel. No telecommuting. Job duties are project-based & performed on long-term assignments at various unanticipated sites within the US which may require relocation at the end of the project.Additional Information:●Job Site: 731 Alexander Road, Ste. 101, Princeton, NJ 08540●Salary: $112,299 per year.●Email resumes to hr@ls-sol.com●No calls. EOE.●Must be legally authorized to work in the United States without sponsorship.#LI-DNI