Sr Engineer
Ultimate Solutions View all jobs
- Juncos, PR
- Permanent
- Full-time
- 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.
- 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 Basic technical report writing
o Verbal communication
- Comprehensive understanding of validation protocol execution requirements.
- Demonstrated Skills in the following areas:
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 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 Collaboration
o Project cost development
o Conflict Resolution
o Leadership and teambuilding
- Management of contractors and vendors