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QC Equipment Qualification Engineer

  1. East Coast
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
07-12-2023
32590
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QC Equipment Qualification Engineer - Raleigh, US - 18-Month Contract 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented QC Equipment Qualification Engineer 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.


Responsibilities:
  • Leverage existing processes, procedures, and documents from other facilities where possible to provide an efficient CQV activities for the project
  • Assure suitability and/or cGMP compliance of equipment in quality control
  • Create and maintain project document QC approval plans and status updates
  • 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:
  • Have a good general understanding of relevant quality control testing processes and equipment
  • Experience in QC Laboratory equipment selection, qualification, and managing service contracts
  • Strong working knowledge of QC Laboratory equipment and software
  • Have Up-to-date knowledge of agency requirements for quality control testing and specifications
  • Have knowledge of multi product product facilities, preferable ADE / PDE
  • Be familiar with risk-based approach, preferable the ASTM E2500 standard for qualification
  • Be able to review, understand and partner to assure suitability and/or cGMP compliance of equipment
  • Have excellent communication / presentation skills, and be able to articulate complex information to stakeholders and supporting functions such as CQV, QA, Engineering, Automation, and others
  • Solid knowledge of Computer System Validation process
  • Be a team player who works well with colleagues and cross-functional teams
  • Be a self-starter and have a flexible, proactive, and dynamic approach to completion of work objectives and working with colleagues
If this role is of interest to you, please apply now! 

The candidate must have the rights to work in the location stated in the job advert.

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