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Senior Cleaning Validation Engineer

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
35252
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Senior Cleaning Validation Engineer– Pharmaceuticals – Contract – North Carolina

Our client, a global pharmaceutical manufacturing organization are looking for a talented Senior Cleaning Validation 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.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Participate in CV conversations for CQV but including all necessary functions such as, but not limited to operations, QA, QC, process support, supply chain, etc and gain alignments as needed.
  • Liaise with the operational readiness team and third party contractors, as applicable, to build the connection and define interactions with operations as it relates to cycle development and hold times
  • Document a strategy for how CV will be executed at the site.
  • Write and review cleaning and sanitization procedures and maintaining the Cleaning Validation Master Plan
  • Work with CV team at sister site in Denmark to clone where possible from SOPs, methods, etc. and develop a plan for localization of these in Holly Springs
  • Define roles and responsibilities during CV and gain alignment from supporting teams
  • Together with the CV lead develop a communication strategy to ensure the site is informed about CV and work with the head of CQV to launch
  • Work with project managers to develop tracking tools and visibility to CV activities
  • Ensure our plan aligns with all necessary regulations and will support successful qualification and future site regulatory inspections
  • SME for presentation of cleaning validation to Regulatory (FDA), internal and external auditors.
If you are interested, please apply now for immediate consideration and further information.

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