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Serialization Engineer (Track & Trace)

North Carolina, North Carolina
Serialization Engineer (Track & Trace)

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has deliver proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.


Description

The candidate will provide technical support on all system/equipment optimization strategies, upgrades, and ensure that all the activities follow current corporate policies, industry standards, regulatory standards and FDA standards. 

 
 Requirements
  • Bachelor’s degree in Engineering or related technical area
  • 2+ years packaging, automation, or software experience, specifically related to secondary packaging processes and equipment.
  • 2+ years experience in GMPs and computer systems validation (CSV).
  • Comprehensive understanding of validation protocol requirements.
  • Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP, SAP+) and manufacturing execution systems (MES).
  • Knowledge of machine vision technologies including image analysis and inspection Experience interfacing with vision hardware components and familiarity with connectivity protocols.
  • Experience in SYSTECH Serialization solution is a MUST.
  • Knowledge in Cognex system is a plus.
  • Experience in serialization and full track and trace, as well as experience with product labeling, track and trace methodologies and regulatory compliance related to anti-counterfeiting measures.
  • Experience in Packaging equipment troubleshooting.
  • Basic knowledge and understanding in Control Systems such as PLC, HMI, etc.
  • Candidate must possess Regulatory Experience in the Life Science Industry.

 Skills and Qualifications
 
  • Interpersonal, problem solving
  • Fully bilingual: oral and written
  • Takes initiative, works with minimum supervision
  • Experience in Equipment Maintenance
  • Leadership and team building
  • Verbal communication and written Communication/Technical Writing
  • Facilitates and Organizes
  • Technical (Equipment Specific)
  • Analytical Problem Solving
  • Computer Literacy
  • Manages changes at work


Ultimate Solutions Corp is an Equal Opportunity Employer.
 

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