Calibration Manager

Fortive; Juneau (AK); On-site; USD 60,000 - 90,000; Full time

Job summary

Mentor Technical Group provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. The team leads calibration and instrumentation work across the USA & PR region, in line with CFRs, cGMPs, ISO standards and SOPs.

Educational requirements include an AD in Electronics or an Engineering/Science degree plus experience presenting to regulatory authorities including FDA and PLC troubleshooting or programming in related industries.

Qualifications

• AD in Electronics, Instrumentation.
• Engineering or Science degree or related experience.
• Experience presenting to regulatory authorities including FDA.
• Years’ experience with strong knowledge in PLC troubleshooting and/or programming within relevant industries.

Responsibilities

• Perform basic calibrations of instruments on process and utility equipment.
• Assist the team with maintaining and up-to-date spare parts inventory system.
• Ensure calibration paperwork and work order documentation are complete and accurate.
• Lead cross-functional team across the USA & PR region.
• Partner with sales on new business opportunities to support objectives.

Skills

Calibration

Team leadership

Customer relationship management

Education

AD in Electronics

Engineering or Science degree

FDA regulatory presentation experience

Tools

PLC troubleshooting

PLC programming

Regulatory compliance tools

Job description

Full 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.

Qualifications and responsibilities

• Perform basic calibrations of instruments on process and utility equipment.
• Assist the team with maintaining and up-to-date working spare parts inventory system for the equipment/systems the team is responsible for.
• Ensure that calibration paperwork, instrument files and work order documentation is completed with accurate information.
• Participle in a detailed training program in order to develop one’s knowledge in the instrumentation field and other areas of the plant.
• Assist in the development, revision and updating of related SOPs for work related areas.
• All work must be completed in accordance with CFRs, cGMPs, ISO standards and SOPs.
• Lead a cross-functional team of technical, logistics, customer service, and sales personnel that are based throughout the USA & PR region.
• Develop, recruit and retain personnel resources to build an effective team.
• Implement the quality management system to achieve customer fulfillment, support new business, and achieve market growth.
• Own the customer relationship; establish and foster customer intimacy through routine interaction with key customer representatives.
• Partner with sales counterparts on new business opportunities to develop support strategies that will facilitate achievement of annual business objectives.
• Manage employee relations to ensure a progressive workforce.
• Support and enhance the “Fortive Business System” culture by driving continuous improvement in all areas of business and personally utilizing Growth, Lean and Leadership tools.
• Promote the use of right FBS tools to analyze and solve high-priority problems, ensuring process-based countermeasures and root cause analysis.
• Other duties as assigned by director, upper management or by the client.

Educational Requirements

• AD, in Electronics, Instrumentation.
• Engineering or Science degree or related experience.
• Experience in presenting to regulatory authorities including FDA.
• Years’ experience with strong knowledge in Programmable Logic Controller (PLC) troubleshooting and/or programming within the Pharmaceutical, Biotechnology, Medical Device, Food and Beverage, Cosmetics and Healthcare Industries.

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.