Cleaning Validation Engineer

Company: Agilent
Location: Boulder
Posted on: January 6, 2022

Job Description:

As a federal contractor and healthcare company committed to protecting the health and safety of our employees, contractors, customers and communities, employees in the U.S. and Puerto Rico are required to be fully vaccinated against COVID-19, unless an approved exemption has been granted for a medical reason, sincerely held religious belief, or an employee is otherwise exempt under applicable law.Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us. Information about Agilent is available at it like to work at Agilent in Manufacturing? Watch the video"In this role, you'll be responsible for the execution of cleaning validation activities at the Active Pharmaceutical Ingredient (API) manufacturing sites of Agilent Technologies Nucleic Acid Solutions Division. Generating and executing validation study documentation including protocols, cycle development notebook studies, final reports, deviations, and SOPs while ensuring compliance with cGMP requirements.Essential duties and responsibilities:Leads the improvement of practices, Designs and develops cleaning procedures for new products and manufacturing equipment and supports the implementation, i.e. provides training of cleaning strategies for product transfer projects and product development projects.Provide technical support to cleaning activities associated with the manufacturing process and represents cleaning program in client and regulatory auditsInvestigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under development cleaning proceduresWorks multi-functionally to ensure alignment to cleaning program documentation and site initiativesDevelops technical and manufacturing documents necessary for development studies, cleaning validation, and post-validation process verification, in alignment with corporate and industry standardsExamines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve it at root causeMaintains alignment with internal technical personnel regarding validation practices for products, processes and equipment and partners with cross- functional areas on validation study implementationAssists with validation planning and risk assessments associated with validation activities.Resolves CAPA's, nonconformances, protocol incidents, and change controls related to validation protocols.The Salary Range for this position is: $87,600 - $109,500Benefits included in the brief.

Keywords: Agilent, Boulder , Cleaning Validation Engineer, Engineering , Boulder, Colorado