Cleaning Validation Engineer - North Carolina - 12-Month Contract
Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Cleaning Validation Engineer to join their new and exciting large-scale CAPEX investment programme.
With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.
Main Responsibilities
- 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
Experience
- Cleaning Validation Engineer.
- Experience in CIP and parts washers along with who how to troubleshoot and identify common issues
If this role is of interest to you, please apply now!
LI-MC1
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