Ultimate Solutions is a Global Leader in Validation, Serialization, Industrial Automation & Compliance for the Life Sciences Industries.
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.
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.
In addition, candidate must have experience in Sampling Plans, Change Controls and pFMEA creation and review.
Bachelor degree in Chemical/ Industrial/ Mechanical Engineering and 2-5 years of related experience.
Competencies / Skills
Ultimate Solutions Corp in an Equal Opportunity Employer.
- Knowledge of applying six sigma statistical tools, processes and programs.
- Familiarity with documentation process.
- Ability to work on specialized statistical software such as Minitab and Excel.
- Ability to apply industrial engineering and process improvement to production.