At Kelith, we're more than just a company – we're a community of passionate individuals dedicated to making a difference. We believe that the key to our success is our people, and we are constantly on the lookout for talented and driven individuals to join our team.
Kelith Group is currently seeking a Validation Engineer with at least a Bachelor’s Degree in a relevant engineering discipline (mechanical, pharmaceutical, chemical), or a related life sciences field. Any candidate must be familiar with validation life cycle documentation, writing installation, and CAPA. This position entails ensuring all systems are running according to necessary specifications and operating within regulations to ensure the production of quality products, as well as establishing validation standards, developing testing protocols, preparing equipment, documenting test results, and maintaining records for later analysis.
Kelith Group is currently seeking a Software Developer with a minimum of a bachelor’s degree in computer science, computer information systems, information technology, related engineering (electronics or computer), or a directly related field. The position is seeking a skilled Power Platform Developer to join our dynamic team. In this role, you will be responsible for streamlining processes, automating tasks, and providing actionable insights using Microsoft Power Apps, Power Automate, and Power BI.
Kelith Group Inc has openings for the positions of Validation Engineer with master's degree in Mechanical/Manufacture Engineering, Management, or related and 1 year of Experience in executing Engineering test plans (ETP) for new and modified systems/equipment. Develop protocols for validation/testing of equipment and processes. Maintain/prepare validation documentation. Calibrate equipment for accuracy. Lead Corrective/Preventative Action (CAPA) and failure analysis processes and documentation. Experience with Gage R&R, PFMEA, Control Plans, and Process Flow documentation as part of component part validation processes (IQ, OQ, PQ). Knowledge and understanding of driving regulations and standards FDA, QSRs, ISO, FDA 21 CFR Part 11. Support internal and external audits of validation procedures and provide validation support.
Work location is Princeton, NJ with required to travel and work from various unanticipated client worksites throughout the USA. Mail resumes to 5 independence way, Suite 120, Princeton, NJ-08540. (OR) e-mail: hr@kelithgroup.com