Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units.Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience.
Ultimate Solutions Corp is an equal opportunity employer.
- Experience with Assembly, Tester and Packaging processes and machines support
- Basic knowledge and experience on Medical Device/Combo Product processes and regulations
- Basic metrology and testing experience
- Validation and Characterization experience (Protocols/URS/DS/IOQ/PQ)
- Basic project management skills
- Basic experience in medical device assembly process
- Technical Report writing skills
- Basic statistical knowledge
- Basic Machine troubleshooting
- Basic automation knowledge (PLC, HMI, Drivers, Motors, Profibus, Device Net, Control Net)
- Able to work in any shift as required by the projects and activities