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
Top Skills
What We Do
MENTOR Technical Group is a team of highly educated, superior trained, and dedicated professionals with expertise and experience to provide a complete portfolio of technical support and solutions for the FDA-regulated industry. MENTOR Technical Group delivers solutions with a flexible cost-effective approach to meet your company’s needs. Our purpose is to help you bridge the gap between your business strategies and results, by balancing three major aspects: People, Regulatory and Compliance, and Technology.
MENTOR Technical Group’s objective is to deliver reliable tailored solutions—from consultation to becoming part of your staff. This proximity helps us develop customized frameworks to help you unlock the hidden value in your plants, facilities, equipment, and staff, while optimally integrating resources, regulations, and technology.
MENTOR Technical Group’s commitment begins by getting involved from the conceptual phase up to the implementation phase of your projects. Our management staff has unparalleled experience in both the operating and consulting industries. We have over 200 technical staff members, which allows for efficient project execution.
At MENTOR Technical Group, we deliver on our commitments—every time, on time. Our enthusiastic highly skilled workforce consistently meets or exceeds client expectations. We don’t just perform for our clients; we work with integrity. Our professional staff takes pride in their work and acts with a sense of ownership.
