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Quality Control Engineers

  1. United States
North Carolina
  1. Contract
Competitive
  1. Compliance / Quality Assurance
09-04-2024
33829
QC Equipent Qualification Engineers - North Carolina - 18-Month Contract 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented QC Equipent Qualification Engineers to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Main Responsibilities:

  • Lead the QC Laboratory equipment selection and digital solutions
  • Ensure delivery and implementation of solutions which fulfill requirements and expectations of the end users
  • Author and implement project plans, validation plans, user requirements, standard operating procedures, and any other documents to support QC equipment and instrumentation for the QC laboratories
  • Report on status and manage escalations
  • Ensure systems remain in a validated state and manage their lifecycle as the facility comes on line
  • Identify and capture new opportunities to improve or optimize QC Lab systems
  • Ensure inspection readiness with respect to QC equipment and instrumentation

Requirements: 
  • 8+ years’ experience from similar role in large Pharma/ Biotech projects
  • Master's or bachelor’s degree within IT, Physical, Chemical or Biological Science, Technical Engineering or equivalent
  • Experience in QC Laboratory equipment selection, qualification, and managing service contracts
  • Strong working knowledge of QC Laboratory equipment and software
  • Solid knowledge of Computer System Validation process
  • Must be a self-starter, be able to work with minimal supervision and effectively manage multiple projects
  • Collaborative attitude with the willingness to work with global peers toward company and department goals.
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines
  • Excellent oral and written communications skills in English
 
 

If this role is of interest to you, please apply now! 

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