Utilities Engineer

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.

Qualifications Requirements/Knowledge/Education/Skills/Responsibilities:

• SME with a deep technical expertise in all systems under his/her responsibility (GMP HVAC, GMP Utilities and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, well versed with flow charts and process parameters, and awareness of industry trends.
• Ensure the assigned processes are in alignment with the applicable regulatory Industry and Civica Standards.
• Support risk assessment exercises using the different tools available (eg.FMEA) and participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals.
• Lead or participate in projects/changes for all the systems under his/her responsibility including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
• Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state.
• Monitor utility systems to assure that they are operating properly, in compliance with requirements.
• Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters.
• Implement efficient and effective maintenance and reliability techniques.
• Apply problem solving skills by leading equipment failures, troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues.
• Provide customer consultation and notifications on issues that involve utilities areas. Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date.
• Provide technical assistance as necessary to maintenance, and operations personnel.
• Support internal and external inspections and investigations (including Quality and HSE).
• Maintain efficient communications with appropriate site customer groups.
• Proficiency with the DMS and CAPA systems.
• Maintain, develop, and conduct operations training of utility systems.
• Utilize statistical analysis tools to determine the process control, and capability for investigations.
• Participate in Process Hazard Review meetings and/or Safety Teams as required by leadership
• Support expansion project with Commissioning of the mechanical utility systems (HHW, AHU, Chiller, Boiler, etc.), mechanical utilities with the startup of the BMS/EMS, Procedural updates (modifications and new) for the new utilities, CMMS (Deacom or BM) data setup, Calibration setup, qualification of the process utilities, others.

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.