Sr Engineer - 33198

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Mirus Consulting Group Juncos , PR

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mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.Job Description

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

Preferred Qualifications

Knowledge in GMP/Regulated industry
Knowledge in Packaging equipment.
Knowledge in Design of new equipment process.
Knowledge in Engineering Project
Knowledge in Validations
Experience in Medical Device or Pharma
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

Education

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

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

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