Validation Engineer II
Location: Lancaster, Pennsylvania
Posted: November 25, 2016
Reference ID: 368757360
The Senior Engineer, Cleaning Validation is responsible for providing technical support in the areas of development, validation and monitoring of cleaning processes and equipment. The individual provides technical experience and leadership for cleaning development, validation and monitoring while collaborating with Manufacturing, Operations, Research and Development, Quality Control, Quality Assurance, Process Excellence and other affiliated departments. Experience in CIP/COP and manual cleaning validation activities are required. Experience troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred. Experience Developing documents and SOPs and prepare reports is required. Must have ability to analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures. Address discrepancies and resolve deviations. Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation. Train operations staff on protocols, procedures and technical details related to systems or processes. Organize, schedule and track validation projects in order to meet client requirements and agreed timelines. EDUCATION/EXPERIENCE A minimum of a BS in Engineering or Technical field is required. A minimum of 5 years of industry experience is required with at least 3 years of Cleaning Validation and/or cleaning development experience is preferred. Specific experience within the Consumer, OTC, or Pharmaceutical industry is preferred. GMP experience is preferred. Experience in a highly regulated environment is preferred. Demonstrated technical knowledge related to cleaning development and validation is required. Ability to work in a cross functional environment relating to R&D, Marketing, Operations, Sales, etc is required. Previous experience focusing on managing and/or supporting technical projects is required. Proficiency in MS Office applications is required, especially with Excel and PowerPoint. Experience in customer focus, program/project management, accountability, process orientation, and strategic thinking is required. Experience in process excellence and process thinking and application of tools is preferred. Six Sigma or Process Excellence certification is preferred. Negotiation skills, ability to effectively work with peers, strong leadership and analytical skills. The ability to establish project criteria, monitoring activities and successfully execute several projects concurrently is required.