The Role
Lead characterization and optimization of manufacturing equipment and processes. Own CMMS activities, improve reliability and availability, reduce downtime, develop performance metrics, lead equipment improvement projects, act as SME for design/maintenance, support troubleshooting, manage CAPAs and deviations, and drive EHS compliance.
Summary Generated by Built In
We are seeking a Sr. Engineer that provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
- Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.
- Collaborate with engineering staff to ensure the best maintenance strategy on manufacturing equipment operations.
- Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization
- Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.
- Lead the implementation of equipment improvements projects
- SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.
- Support equipment troubleshooting within the functional area or in the scope of technical expertise.
- Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization
Requirements
Skills Required
- Doctorate degree in Engineering
- Master's degree in Engineering with 3+ years of engineering experience
- Bachelor's degree in Engineering with 5+ years of engineering experience
- Bilingual (English and Spanish)
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
