Sr Engineer
mîrus Consulting Group
- Juncos, PR
- Permanent
- Full-time
- 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
- 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.
- Other functions may be assigned
- Design Engineering:
- 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
- Knowledge and experience working with Change Controls on trackwise. (Prefer experience that we are looking)
- Knowledge in Packaging equipment.
- Knowledge in Design of new equipment process.
- Knowledge in Engineering Project
- Knowledge in Validations and Commissioning
- Experience in Medical Device or Pharma
- Knowledge in CAPA and Compliance
- 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.
- Apply engineering science to production.
- Able to develop solutions to routine technical problems of limited scope
- Problem solving and applied engineering.
- Basic technical report writing
- Verbal communication
- Comprehensive understanding of validation protocol execution requirements.
- Basic technical presentations
- Personal Organization
- Validation Protocol Writing
- Dealing with and managing change
- Technical (Equipment Specific)
- Analytical Problem Solving
- 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
- Schedule development
- Facilitation
- Collaboration
- Basic project management
- 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.
- Working knowledge of financial analysis tools
- Ability to delegate and manage the project work of others
- Negotiation, persuasion and facilitation
- Collaboration
- Project cost development
- Conflict Resolution
- Leadership and teambuilding
- Management of contractors and vendors
- Doctorate degree or Master degree and 3 years of Engineering experience or Bachelor degree in Engineering and 5 years of Engineering experience.