Cleaning Validation Engineers - North Carolina
VTI Life Sciences
- Raleigh, NC
- Permanent
- Full-time
Industry: Pharmaceutical Manufacturing
Level of Experience: 4+ years
Location: North Carolina, USA (On-Site)
Duration: Through the end of the year + (Initial Contract)Job Description
- Past work in a CDMO or a drug product facility is needed.
- 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, including autoclaves, 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
- Candidates must be Full Time Employees or 1099 contractors. Corp to Corp candidates are not allowed by the client.