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CQV Engineer

  1. East Coast
  1. Contract
Competitive
  1. CAPEX Projects
30-05-2023
31462

This vacancy has now expired

CQV Engineer – Life Science – Contract – North Carolina

Our client, a global Pharmaceutical manufacturing organization are looking for a talented CQV 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.

CQV Engineer Responsibilities:
  • Collaborate with cross-functional teams, including engineering, quality, and manufacturing, to develop comprehensive CQV strategies and plans for the pharmaceutical project.
  • Design, review, and execute commissioning, qualification, and validation protocols (IQ, OQ, PQ) for process equipment, facilities, and utilities, ensuring compliance with regulatory guidelines
  • Support execution of all UST systems and CQV deliverables; FAT/SAT/IOQ
  • Support Weekly CQV UST Meeting and ensure updates are provided to Weekly CQV Meeting.
  • Generate and ensure timely approval of all SAT and IOQ Final Reports.
  • Conduct risk assessments and gap analyses to identify areas of improvement and develop mitigation strategies to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
  • Coordinate and oversee the execution of CQV activities, including scheduling, resource allocation, and documentation.
About you:
  • Minimum of 3 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Minimum 3 years experience in Leading Equipment CQV Team
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organizing and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Paperless Validation Software, Spreadsheets, Word Processing, Visio, Microsoft Project)
 

Are you a good fit for a CQV Engineer? Get in touch with us today.



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