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Sr Engineer (Process/Equipment Validation)

Juncos, PR
Description
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Responsibilities
Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures. Develop engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area. Application of mature engineering knowledge in planning and conducting projects. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints. Coordinate the work of consultants, architects and engineering firms on development of standard design documents. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Education
Doctorate degree or Master’s degree and 3 years of Engineering experience or Bachelor’s degree in Engineering and 5 years of Engineering experience.

Requirements
  • Process and Equipment characterization and validation
  • In-depth knowledge of validation processes and requirements as applied to new equipment installations
  • Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
  • 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

Ultimate Solutions Corp is an equal opportunity employer.
 

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