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Cleaning Validation Engineer

  1. United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
35252nr
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Cleaning Validation Engineer - Pharma - North Carolina - 12-Months 

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


Main Duties:
  • 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.
  • Identify all necessary SOPs and need by dates and work with owning functions to ensure delivery
  • Work in partnership with QC teams to determine the appropriate CV methods and sampling strategies
  • Work in partnership with the Supply Chain teams to develop a material resourcing and storage strategy to support CV activities, as needed
  • Develop a strategy in collaboration with QC and Operations, for ensuring training of personnel ahead of executing CV on site
  • Work with the CQV leads, CV lead, REs, and QA on the implementation of the CV strategy in their respective areas
  • Develop a high level documentation plan and work with the Kneat leads to ensure templates are ready for execution of these documents
  • Localize documents and applicable CV related SOPs to the FDBN site
  • Perform investigation of deviations and/or discrepancies

Responsibilities: 
  • Minimum 10 years experience on a large scale project
  • Minimum 10 years working in a Cleaning Validation role, either as a senior engineer or lead
  • Experience of a greenfield project would be a bonus
  • Able to start at the end of November to do handover
  • Full time on site

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

 #LI-MC1
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