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:
- Author, revise, and maintain SOPs and related controlled documents in accordance with regulatory and company standards.
- Collaborate with cross-functional teams (e.g., QA, QC, Manufacturing, R&D, Regulatory) to gather process information and ensure SOPs reflect current practices.
- Ensure SOPs are clear, concise, and user-friendly, enabling consistent execution by staff.
- Manage document lifecycle using electronic document management systems (EDMS), including version control, approvals, and archival.
- Support internal and external audits by ensuring documentation is inspection-ready.
- Train staff on new or revised SOPs and maintain training records.
- Continuously improve documentation practices to enhance clarity, compliance, and usability.
Qualifications Requirements/Knowledge/Education/Skills:
- Education: Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field.
- Experience: 2–5 years in a regulated industry (pharma, biotech, medical devices) with direct experience in SOP writing or quality documentation.
- Knowledge of regulations such as FDA 21 CFR Part 11, ISO 13485, ICH Q10, and GxP principles.
- Proficiency in EDMS (e.g., Veeva, CDOCS, Kneat, AML, MasterControl, Documentum).
- Strong writing and editing skills, with the ability to translate complex processes into clear instructions.
- Attention to detail and strong organizational skills.
- Excellent communication and interpersonal skills for cross-functional collaboration.
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.
