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 ensures 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:
Review and audit validation, qualification, and verification activities across manufacturing, packaging, utilities, facilities, laboratories, and systems.
Participate in defining validation/qualification strategies for product transfers and site product changes, including regulatory impact assessments.
Review and approve Operational Qualification (OQ), Performance/Process Qualification (PQ), and Verification activities, along with associated SOPs.
Review and approve analytical test method validation/verification reports, specifications, test methods, laboratory instrument qualifications, periodic reviews, risk assessments, commissioning documentation, installation certifications, and master batch records for manufacturing and packaging.
Coordinate Change Requests (CRs) for qualified production records, equipment, systems, and facilities, including review, tracking, safekeeping, and closure of CRs.
Assess the regulatory impact of proposed changes and ensure completeness of documentation prior to approval.
Support PCF sponsors in preparing change requests by providing regulatory documentation.
Create and revise export profiles for assigned products.
Support activities related to new R&D products, including change controls, development, and validation documentation.
Contribute to the APR process.
Review documentation and change controls related to shipping labels and artwork.
Qualifications / Requirements / Knowledge / Skills:
Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field.
Proven experience in validation, qualification, and verification within a pharmaceutical manufacturing environment.
Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.
Experience with Change Control processes, regulatory impact assessments, and cross-functional coordination.
Excellent skills in reviewing, auditing, and writing technical documentation.
Ability to manage multiple projects and prioritize tasks effectively.
Strong analytical, problem-solving, and communication skills.
Proficient in MS Office applications (Word, Excel, PowerPoint, etc.).
Bilingual: fluent in English and Spanish preferred.
Skills Required
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field
- Proven experience in validation, qualification, and verification within a pharmaceutical manufacturing environment
- Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements
- Experience with Change Control processes, regulatory impact assessments, and cross-functional coordination
- Excellent skills in reviewing, auditing, and writing technical documentation
- Ability to manage multiple projects and prioritize tasks effectively
- Strong analytical, problem-solving, and communication skills
- Proficient in MS Office applications (Word, Excel, PowerPoint, etc.)
- Bilingual: fluent in English and Spanish preferred
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.
