Validation experience– ISO Documentation experience (can train on this but must be willing to be trained on it)
Continuous improvement/Digitalization
ROI
Process Improvements
Required Knowledge, Skills & Abilities
Bachelor's Degree in Mechanical, Electrical, Robotics, Automation, or other relevant Engineering & Technology disciplines with 5+ years of experience, OR equivalent combination of education and experience.
2+ years' hands-on working experience with Automation Systems Projects for Robotics, PLCs, HMIs, Machine Vision, Servos, Labelers, Fillers, Kitting, Sorting, and Packaging
2+ years' experience implementing ERB, MES, and/or SCADA systems
2+ years' experience with process/equipment validation: writing documentation and execution - IQ, OQ, PQ
Strong technical, project management and documentation skills
Self-starter, highly organized, complex problem solver with technical, detail-oriented mindset and strong analytical and communication skills
Demonstrated ability to work in a regulated environment
Preferred Knowledge, Skills & Abilities
Knowledge of FDA QSR requirements, ISO 13485, or other recognized international quality system standards
Prior experience in working with and/or managing suppliers and/or subcontractors
Experience with FMEA, DOE, SPC
CAD, and Project Management software experience
Experience with SAP, Agile, and other related ERP and PLM systems
Prior hands-on experience with programming Fanuc and Denso robots, Omron and Allen Bradly PLC, HMIs, Cognex Vision Systems, Zebra, and Sato Labelers
Knowledge of Industry 4.0, AI, Machine Learning, Data Science, predictive analytics, and touchless transactions
Preferred SKILLS AND CERTIFICATIONS Robotics & AutomationProject Management - Capital EquipmentValidation/ISO Documentation