Candidate with experience in regulated environment industries such as Medical Device, Pharmaceutical, Bio-pharmaceutical or other FDA regulated industry.Technical validation engineering expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of processes, systems or facilities.The potential candidate will provide technically feasible improvement plans/proposals in support of process and equipment, replacements, and modifications in the laboratory, manufacturing, or manufacturing support environments. Applies basic Quality Engineering principles along with Six Sigma tools to design and implement system or process modifications. Will evaluate, select and apply Quality Engineering techniques and procedures. Function as a technical Quality Engineering expert to analyze and troubleshoot variety of processes. Experience working with facilities and utilities areas; system evaluations and protocol revisions.
Working with manufacturing process, maintenance, process development, utilities, facilities, labs, and quality assurance in developing requirements and recommendations for system modifications an evaluations. Experience conducting internal audits.
Bachelor degree in Engineering Field 1-3 years of experience.
Knowledge of applying six sigma statistical tools, processes and programs. Familiarity with documentation process. Ability to work on specialized statistical software such as Minitab. Ability to analyze and apply GLPs and GMPs to improve the quality of the system. Ability to apply industrial engineering and process improvement to production.
Ultimate Solutions in an Equal Opportunity Employment