Field Service Engineer (Regulated Industry)

Job Description

Job Description

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:

• Collect service reports for CM, PM, Cal, Qual and upload copy to CMMS work order
• Ensure Field Service Report completion and follow-up actions are documented in CMMS
• Asset Status Labeling (e.g., calibration labels)
• Physical Inventory
• Escort Vendors (Third Party) and ensure compliance with facility policy and work standards
• Ensure Vendors comply with PPE policies (Lab Coat, Safety Glasses, Gloves)
• Triage instrument up to 30 minutes to determine if instrument/equipment is repairable on-site
• Perform PMs/Cal service if applicable and within skillset
• Own Work Orders for on-site instrument repair:
• Instrumentation for all equipment that Engineer is trained/certified on
• CATI, II or III as defined by Engineer level supporting site 
• Client and non-Client instrumentation
• Create Work Requests on multiple CMMS systems and Notify Manager/Planner of required off-site instrument repair needs
• Complete work documentation in CMMS systems (comply with data integrity)
• Assist with installation / decommissioning of equipment
• Tags equipment “Out of Service” if, upon calibration, the equipment cannot be brought back into the calibration tolerances

Qualifications Requirements/Knowledge/Education/Skills:

• Bachelor's degree is required; Sciences or Engineering is preferred.
• Minimum of five (5) years professional experience with research and/or manufacturing laboratory equipment/instrumentation within the regulated industry.
• Requires good technical writing skills.
• Computer literacy with MS Office applications (Word, Excel, Power Point, Outlook) and Computerized Maintenance Management System (CMMS), (e.g. Maximo).
• Above average organizing, analyzing and a minimum of math (practical application of fractions, percentages, ratios, proportions, basic algebra) to determine organizational, Customer and regulatory problems and formulate corrective action plans.
• Requires effective interpersonal skills as demonstrated through prior experience.
• Ability to work independently under minimal guidelines and supervision.
• Working knowledge of applicable regulations and standards, including, but not limited to, GMP, GDP regulations and ISO standards.
• Demonstrated ability troubleshoot laboratory equipment and instrumentation.
• Clear Communication and Customer Service skills.

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.

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