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.

Responsibilities:

• Provide general facility upkeep and responsive customer support with emphasis on customer satisfaction.

• Communicate and coordinate with other departments on regular basis to ensure planned and unplanned work is properly prioritized and arranged for smooth implementation.

• Proactively escalate risks to management for any issue that may impact the business goals of the department and site.

• Use the CMMS system to review work requests, identify and ensure availability for required stock/non-stock materials, perform work orders to completion, and maintain associated equipment logbooks.

• Perform predictive, preventive, and corrective maintenance activities and calibrations to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and unscheduled work.

• Troubleshoot and repair, with minimal supervision, complex utility systems which may include Heating Ventilation and Air Conditioning (HVAC), electronic control systems, electrical, compressed air and gases, Reverse Osmosis (RO), wastewater treatment, and/or other Biotech/pharmaceuticals utilities.

• Use BAS (Building Automation System), EMS (Environmental Management System) and BMS (Building Management System) to monitor and troubleshoot issues throughout the plant.

• Take on SME (Subject Matter Expert) roles for multiple facility and equipment systems and engage in continuous learning and knowledge expansion.

• Work with equipment owners/engineers and direct the performance of work by equipment vendors.

• Interpret drawings, layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.

• Be involved in new equipment and plant systems installs as necessary. Provide day to day technical assistance to the Engineering Services, Metrology, and Validations groups.

• Assist in qualifying vendors for external calibration services and review calibration certificates. • Escort and help manage vendors and other personnel performing work while on-site at any Matica Biotechnology location.

• Review Scope of Work by contractors and other venders before work is started, monitor work being completed, verify work completed and check quality of work.

• Maintain cGMP records, both paper-based and electronic.

• Participate in authoring accurate documentation for the operation and maintenance of various utility systems, supply information and technical data for securing spare parts.

• Perform calibrations in the following: Balances/scales, flow, temperature, conductivity, pressure, among others in a GMP/GXP environment.

• Perform corrective and preventative maintenance of equipment such as agitators/mixers, chromatography columns, glass washers, and various sanitary design pumps and valves within a cleanroom environment.

• Develop and Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.

• Support regular day shift operation of facility and respond to facilities issues as needed. Provide on-call support as required.

• Respond to alarms and document activities in accordance with cGMP requirements. Work with equipment owners and develop remediation activities for alarms.

• Administer and perform hazardous energy control procedures and confined space entry.

• Provide project leadership and management on projects increasing in magnitude and scope.

• Understand Asset Management, routine reliability concepts, and provide reports for asset performance.

• Other assigned facility maintenance and engineering related tasks or other duties as required.

Qualifications Requirements/Knowledge/Education/Skills:

• AS or BS degree in a science/technical field or a technical trade school degree preferred – or combination of education/certifications and experience

• Minimum 2 years of relevant experience working in a regulated controlled or cleanroom (cGMP preferred) environment

• Minimum 2 years of experience with HVAC systems

• Basic understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work

• Military training equivalent of above is acceptable

• Experience working independently with little to no supervision.

• Experience working for a maintenance organization in a cGMP Biotech/Pharmaceutical manufacturing environment preferred

• Experience with Metrology is preferred

• Understanding of PLC controls for simple troubleshooting is preferred

• Experience in auditing and manipulating BAS / BMS systems preferred

• Licensure in any of the following areas: Refrigeration/Air Conditioning or Electrical is a plus.

• HVAC, maintenance, engineering and other relevant skills necessary to perform job duties required.

• Must be able to use technical expertise and judgement to investigate issues using a structured problem-solving approach to determine root cause and path forward for complex problems.

• Demonstrated ability to learn new equipment/systems.

• Excellent interpersonal and communication skills (verbal and written) required.

• Ability to navigate computerized data and information management systems.

• Ability to present own work to peers and cross-functional managers and provide value to leadership decisions.

• Technical writing skills required.

• Familiarity with Excel, Word, and PowerPoint.

• Ability to gown and gain entry to manufacturing areas to perform essential job duties required.

  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.

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