Engineer

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions MTG has the knowledge and experience to ensure compliance with pharmaceutical biotechnology and medical device safety and efficacy guidelines. With offices in Caguas Puerto Rico and Boston United States we serve life sciences clients in six global markets: United States Puerto Rico Dominican Republic Mexico Germany Canada and South America.

Responsibilities:

• 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.
• 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. 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

Education:

• MS OR BS in Engineering 2 years of Engineering experience.

• Background in Chemical Engineering
• Experience in Biotech companies would be a plus
• Statistical Analyses experience
• Drug substance manufacturing/technical support
• 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: Problem solving and applied engineering. Basic technical report writing
• Comprehensive understanding of validation protocol execution requirements.
• Demonstrated Skills in the following areas: Basic technical presentationsPersonal OrganizationValidation Protocol WritingDealing with and managing changeTechnical (Equipment Specific)Analytical Problem Solving Computer Literacy

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica origen nacional estado de veterano protegido estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by law.