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 and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. 

Responsibilities:

1. Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.

2. Participate in the coordination of TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.

3. Assist during FDA and other regulatory agency inspections. Provide TECHSUPPORT in response to the FDA and other regulatory agencies.

4. Assist in the evaluation and implementation of engineering improvements, policy changes, compliance Improvements and optimization programs.

5. Experience in Packaging Equipment such Thernoformer, Cartoner, Case Packer, Labeler, assembled equipment, Vision System, Serialization, Sensors, Cobots, Mechanical Adjustment, Motor replacement, VFD, PM, Train Tool, PLC Back Up, Pneumatic, Electrical / Mechanical Trouble shooting.

• Other functions that may be assigned

Qualifications Requirements/Knowledge/Education/Skills:

•  Bachelor's degree or Associate's degree and 4 years of directly related experience or High school diploma / GED and 6 years of directly related experience.

Competencies/Skills:

1. Leadership and teambuilding

2. Verbal communication

3. Written Communication/Technical Writing

4. Organization

5. Facilitation

6. Dealing with and managing change

7. Comprehensive understanding of validation protocol requirements.

8. Technical (Equipment Specific)

9. Analytical Problem Solving

10. Project Management & Planning

11. Scheduling

12. Computer Literacy

    Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, 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.

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