Sr Engineer

Ultimate Solutions•Juncos, PR

29d

About The Position

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over 2 decades, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets. 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 EDUCATION Doctorate or Master’s degree and 2 years of Engineering experience or Bachelor’s degree in Engineering and 4 years of Engineering experience 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. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Requirements

Engineer with experience, preferably in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines.
Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI).
Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes
Familiarity with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to interpret and apply GLPs and GMPs.
Ability to apply engineering science to production.
Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas: o Problem solving and applied engineering. o Basic technical report writing o Verbal communication
Comprehensive understanding of validation protocol execution requirements.
Demonstrated Skills in the following areas: o Basic technical presentations o Personal Organization o Validation Protocol Writing o Dealing with and managing change o Technical (Equipment Specific) o Analytical Problem Solving o Computer Literacy
Specialized equipment/process expertise
In-depth knowledge of validation processes and requirements as applied to new equipment installations
Interacts effectively with variety of communication and working styles
Ability to independently determine when additional internal resources are required to solve problems
Ability to handle multiple projects at one time
Demonstrated Skills in the following areas: o Schedule development o Facilitation o Collaboration o Basic project management o Completion and follow-up
Established expertise in at least 3 separate areas of engineering technology.
Ability to independently determine when additional external resources are required to solve problems
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
Working knowledge of financial analysis tools
Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas: o Negotiation, persuasion and facilitation o Collaboration o Project cost development o Conflict Resolution o Leadership and teambuilding
Management of contractors and vendors

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.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.