Senior Engineer
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, Puerto Rico, and Boston and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.Β
Responsibilities:Β
- Provide troubleshooting support as required by operations/engineering
- Analyze downtime incidents as per Equipment Failure, prepare recommendations, create action plans, and execute to eliminate recurrence
- Participate actively in the support of High Skills equipment breakdowns, which could impact the operation with extensive downtime
- Perform or review equipment/system Root Cause Analysis investigations
- Participate in risk assessment and continuous improvement initiatives (Kaizens, critiques, VSMs)
- Generate or support the generation of One-point-lessons for systems/equipment
- Identify, evaluate, develop / design, plan, and implement solutions for equipment/process improvement opportunities
- Development, execution and implementation of corrective and preventive actions (CAPAs)
- Assist in the generation of training materials and in providing training on scientific, and technical operations aspects of the equipment/systems
Education & Qualifications
- Bachelor's degree in Engineering and 5 years of directly related experience orΒ Master's degree in Engineering and 3 years of directly related experience.
- Knowledge in MAXIMO β Owner (RSO), CDOCS β Editor, Owner, Reviewer, Approver, Data Verifier, QMTS β Deviation Initiator and Owner, Change Control Owner and GDMS β Owner.
- Fully Bilingual (Spanish & English)
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Date Posted
12/24/2024
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0
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