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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Essential Functions:
- Contribute to a safe and quality working environment through training, awareness, and compliance to company policy and Federal/State/Local regulations as well as ensuring that all required records are prepared and maintained properly.
- Monitors relevant and applicable regulations and accepted best industry practices and recommend programs, systems and corrective action for application at assigned site and if applicable for enterprise wide consideration.
Responsibilities:
- Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety policies, procedures, and practices.
- Support Safety and manufacturing departments in product transfer activities
- Conduct or review a Risk Assessment / JSA (Job Safety Analysis) for the transfer activity.
- Ensure all SOPs covering product transfer are up to date and approved
- Conducting field inspections.
- Review any required medical surveillance for highly potent APIs.
- Ensure compliance and update the EHS programs documentation.
- Conduct, coordinate, and track various training to support company programs.
- Verify correct PPE selection and confirm engineering controls
- Confirm classification of product potency (OEB level).
- Validate exposure control strategy based on IH recommendations.
- Implement real‑time monitoring if necessary (VOC, particulate, oxygen levels).
- Assess ergonomic risks: Lifting drums, use of pallet jack or forklift.
- Knowledge in Industrial Hygiene procedures.
- Other duties and participation on special projects as required or assigned by manager, upper management or by the client. Implement and maintain a management of change process (MOC) to ensure that business, operational and/or administrative changes that may create adverse effects on people, property or the environment are anticipated, evaluated and controlled early in the process for continual compliance with all applicable regulatory requirements and standards.
Qualifications Requirements/Knowledge/Education/Skills:
- AD, Engineering or Science
- Bachelor’s Degree in Engineering, Industrial Hygiene or Social Science related field.
Physical Requirements and Working Environment:
- While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell. The employee may lift and/or move up to 25-35 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
- He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift/metering stations, manholes, tanks and wet wells. The noise level in the work environment is usually moderately loud.
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.