Cleaning Validation Engineer - Simply Biotech
New Yesterday
Cleaning Validation Engineer - Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a Cleaning Validation Engineer with a biotech company in Durham, NC who possesses: -4+ years of experience with cleaning validation for a life sciences GMP manufacturing facility, experience with Kneat is a plus -Strong prior experience of collaboration with QA, QC, Supply Chain, Operations, Project Managers, and external contractors-Experience developing and implementing site-wide CV strategies and documentation Email resumes to odrow@
FULL DESCRIPTION: The selected candidate will be responsible for: -Past work in a CDMO or a drug product facility is a plus.-Working knowledge of Kneat a plus. -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.-The candidate needs to have current industry Cleaning Validation knowledge for drug products.-The candidate needs to be able to work across functions and departments-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 maintain the Cleaning Validation Master Plan-Work with CV team at their sister site in Europe to clone where possible from SOPs, methods, etc. and develop a plan for the localization of these at their North Carolina facility-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 the 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 the execution of these documents-Localize documents and applicable CV related SOPs to the client site-Perform investigation of deviations and/or discrepancies
The selected candidate will also possess: -Candidates must be Full Time Employees or 1099 contractors. Corp to Corp candidates are not allowed by the client.
Salary Range: $28-$32/hr
For immediate and confidential consideration, please email your resume to odrow@
- Location:
- San Diego
- Job Type:
- FullTime