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
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.
Mentor Technical Group is a minority-owned business setting new standards for multidisciplinary compliance, technical, and engineering services. We partner with leading companies to maintain compliant, reliable operations in life science and other highly regulated industries.
Mentor people make the difference. Our skilled technical professionals and engineers have unique compliance experience and a track record of reliability, responsiveness, and transparency. By leveraging proven processes and this team of specialized professionals, we deliver a comprehensive portfolio of best-practice solutions that give our clients confidence and flexibility for better outcomes.
Our commitment begins at the conceptual phase of a project and follows through to the implementation phase and into operations. With efficiency and innovation always in focus, we work quickly to standardize program improvements across your facilities, reduce risk, and save money. Partnering with Mentor allows your company to focus on core business areas, making the best use of your organizational energy and reduce risk.
Through scalable management and service methods, process integrity and innovation, and an ISO 9001 certified Quality System, we’ve earned recognition for quality, safety, and our status as an accomplished Tier 1 diversity service partner. We maintain these critical capabilities to always ensure we deliver on our commitments—every time, on time.
