Overview:
Mentor Technical Group (MTG) provides specialized technical support and solutions for FDA-regulated industries. MTG is recognized for its expertise in life sciences engineering, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy standards. Resources considered for this RFP will support pharmaceutical manufacturing operations and must meet the following minimum qualifications.
Responsibilities:
Support Commissioning and Qualification (C&Q) activities for plants and equipment.
Develop, review, and maintain commissioning and qualification procedures and documentation.
Write, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production equipment, and lab equipment.
Execute commissioning and qualification activities and coordinate with internal teams and external consultants to ensure timely delivery.
Manage change controls and deviations related to plants and equipment.
Support maintenance and calibration functions to improve compliance and quality.
Provide expertise in troubleshooting and root cause investigations.
Facilitate the transfer of technical knowledge across units and sites.
Qualifications / Requirements / Knowledge / Skills:
Proven background in pharmaceutical product manufacturing, specifically in sterile packaging operations.
Demonstrated experience in Commissioning and Qualification (C&Q) activities.
Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.
More than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilities.
Experience with digital validation solutions (e.g., ALM or equivalent).
Excellent skills in writing validation, commissioning, and technical documentation in English.
Proficient in MS Office applications (Word, Excel, PowerPoint, etc.).
Bilingual: fluent in English and Spanish.
Skills Required
- Proven background in pharmaceutical product manufacturing, specifically sterile packaging operations
- Demonstrated experience in Commissioning and Qualification (C &Q) activities
- More than 5 years of experience in Equipment and Computer System Validation
- Strong knowledge of current Good Manufacturing Practices (cGMP)
- Experience with digital validation solutions
- Excellent skills in writing validation and technical documentation in English
- Proficient in MS Office applications
- Bilingual: fluent in English and Spanish
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.
