With with us

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.

Key Responsibilities
  • Validation Protocols: Develop and execute validation protocols for new products, systems, or processes.
  • Issue Identification: Identify and analyze issues related to product performance, quality, and compliance.
  • Risk Assessment: Perform risk assessments to evaluate the impact of potential issues and develop mitigation plans.
  • Testing and Documentation: Conduct thorough testing, data collection, and analysis, while maintaining detailed documentation of results.
  • Compliance: Ensure that all products and systems comply with industry standards and regulations.
  • Collaboration: Collaborate with cross-functional teams to resolve issues and implement corrective actions.
  • Continuous Improvement: Drive continuous improvement efforts to enhance product quality and reliability.
  • Validation Reports: Prepare clear and concise validation reports to communicate findings and recommendations.
  • Bachelor's degree or equivalent education and experience in a related field.
  • Proven experience in validation engineering or a similar role.
  • Strong analytical and problem-solving skills.
  • Familiarity with industry-specific regulations and standards.
  • Excellent communication and teamwork abilities.
  • Detail-oriented with a commitment to precision and accuracy.
  • Self-motivated and capable of working independently.
  • Proficient in using validation tools and equipment.

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.

Key Responsibilities
  • Develop and Customize Power Apps: Design, develop, and customize Microsoft Power Apps solutions to meet the specific needs of our organization. This includes creating user-friendly interfaces and integrating with existing systems.
  • Automate Business Processes: Utilize Power Automate to automate repetitive tasks and streamline business processes across various departments. Identify opportunities for automation and implement solutions to improve efficiency.
  • Data Visualization and Reporting: Build interactive dashboards and reports using Power BI to provide actionable insights to stakeholders. Translate complex data into easy-to-understand visualizations that drive informed decision-making.
  • Collaborate with Stakeholders: Work closely with business stakeholders to understand requirements, gather feedback, and ensure that Power Platform solutions align with business objectives. Communicate effectively with team members and management throughout the development lifecycle.
  • Maintain and Support Solutions: Provide ongoing support and maintenance for Power Platform solutions, including troubleshooting issues, optimizing performance, and implementing updates as needed. Ensure that solutions remain secure and compliant with company policies.
  • Bachelor’s Degree in Computer Science or Related Field: Minimum of a bachelor’s degree in computer science, computer information systems, information technology, related engineering (electronics or computer), or a directly related field.
  • Experience with Power Platform: Demonstrated experience developing solutions with Microsoft Power Apps, Power Automate, and Power BI. Strong understanding of Power Platform capabilities and best practices.
  • Programming Skills: Proficiency in programming languages such as JavaScript, C#, or SQL. Ability to customize and extend Power Platform solutions using code when necessary.
  • Problem-Solving Abilities: Strong analytical and problem-solving skills with the ability to identify opportunities for process improvement and automation. Experience troubleshooting technical issues and implementing effective solutions.
  • Communication and Collaboration: Excellent communication skills with the ability to effectively communicate technical concepts to non-technical stakeholders. Proven ability to work collaboratively in a team environment and build positive relationships with colleagues and clients.
  • Adaptability and Learning Agility: Willingness to learn new technologies and adapt to changing business requirements. Ability to quickly grasp new concepts and apply them effectively in a dynamic environment.

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