Calibration Specialist

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:

• This position will perform hands on calibrations per cGMP procedures and document the calibration either on paper or through the use of a Computer Based Management System (CMMS).
• Oversee the calibration services provided by vendors and/or contractors at the NCTM facility and assist the Calibration Manager in overseeing contractors, technicians, and/or vendors in Buildings TBF 100/FBF 200 as needed. This position should be able to identify gaps, if any, between outside calibration services and the need of our internal processes.
• Provide calibration advice/training to internal customers, as necessary, on their calibration needs, and instruction if needed for operator performed calibrations, such as PH meters, care and use of check weights, proper maintenance of calibration standards/solutions, etc.
• Assist Calibration Manager in vendor selection, vendor qualification, and service contract negotiations.
• Responsible for the installation, calibration, and document control and relevant quality standards on site.
• Responsible for installation and commissioning service on new equipment and modification of existing equipment.
• Communicate regularly with laboratory and manufacturing supervisors and managers regarding upcoming needs of their areas and the need for timely completion of existing calibration requirements at the NCTM facility.
• Assist the Calibration Manager and communicate regularly with laboratory and manufacturing supervisors and managers regarding the calibration requirements of new equipment as it enters the system.
• Prepare reports, analyzing data, and making recommendations for improving the NCTM facility Calibration program.
• Prepares deviation reports as necessary, for instruments when calibration indicates failure or out of tolerance conditions.
• Develop, update, and/or review Calibration and Metrology SOPs for the NCTM facility; assist the Calibration Manager in maintaining and updating Calibration and Metrology SOPs and other Procedures for Buildings TBF 100/FBF 200.
• Monitors the use and inventories of spare parts and calibration supplies; prepares documentation / justifications and obtains approval to replenish inventory to the Calibration Manager.
• Strong experience with calibration procedures and techniques, including calibration of thermometers, PH meters, pressure and vacuum gages, differential air pressure gages, as well as other laboratory instruments. This will include equipment instrumentation and instruments installed in Loops.
• Strong written, verbal and interpersonal communications skills.
• Ability to work quickly and effectively without constant supervision.
• Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems.​ Must be good with numbers and data with few mistakes.
• Ability to work in a fast-paced environment.​
• Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint). Strong knowledge and ability in Excel or one of several CMMS Database systems, such as Blue Mountain.
• Strong knowledge and demonstrated experience in calibration and documentation requirements for cGMP manufacturing.
• Demonstrated ability to maintain accurate data, accuracy with numbers, ability to identify abnormal data in datasets.

Qualifications Requirements/Knowledge/Education/Skills:

• Bachelor’s Degree with three (3) years overall experience with calibration activities in a calibration or metrology laboratory in a cGMP environment or other FDA or USDA regulated facility required, OR
• Associate's degree with seven (7) years overall experience with calibration activities in a calibration or metrology laboratory in a cGMP environment or other FDA or USDA regulated facility required.

• Experience prolonged sitting, standing, walking, bending, stooping and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Have a normal range of vision.
• The ability to regularly lift and/or move up to 45 pounds and occasionally lift and/or move up to 70 pounds briefly.
• Climb ladders and stairs of various heights.
• Be exposed to wet or humid conditions.
• Be exposed to outdoor weather conditions.
• Be exposed to noisy environments.
• Attendance is mandatory.

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.