Engineer - 33566

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

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures.
• Assistance given for unusual problems.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Initiate and complete routine technical tasks.
• Operations Engineering
• Function as a technical expert to equipment or systems regarding troubleshooting operations.
• Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
• Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
• Design Engineering
• Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Work with consultants, architects and engineering firms on development of standard design documents.
• Obtain and critique quotes for equipment modifications or installations.
• Generate rudimentary project cost estimates and schedules.
• Other functions may be assigned

Preferred Qualifications

• Previous experiences in any regulated environment (Biotechnology, Pharmaceutical, Medical Devices, etc.).
• Experience in Validation with preference in Process Validation.
• 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.
• 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.

Education

• Master's degree OR Bachelor's degree in Engineering & 2 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.