Cleaning Validation Engineers - North Carolina

Job Description

Job Description

VTI Life Sciences (VTI)  is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.

We are looking for up to 10 Cleaning Validation Engineers to work onsite at our client's pharmaceutical manufacturing facility in the Raleigh, NC area.

Job Title :   Cleaning Validation Engineers

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

Requirements

VTI Life Sciences  strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.  VTI  offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations,  VTI  is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time / permanent employees. www.validation.org

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