Cleaning Validation Scientist

JOIN OUR TEAM!PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.General Description:Develop procedures for cleaning processes utilized in operations including cleaning, inspection, and cleaning verification work instructions.Optimize and improve the consistency and effectiveness of cleaning processes developing a validation deliverable, which comply with regulatory guidelines and business requirements.Support employee training to ensure compliance to procedure and process effectiveness.Conduct periodic reviews of the compliance of cleaning processes and to ensure the effectiveness of the cleaning validation program.Coordinate data collection, organization, and archival for cleaning validation program including testing for new and existing products, changes to cleaning processes or equipment, and new equipment.Coordinate sampling logistics (batch identification and tracking).Maintain the Master Data and execute product, equipment, and system evaluations using a risk-based approach including performing required calculations.Design and author technical protocols and reports in alignment with the philosophy defined by the Cleaning Validation engineering team.Compile cleaning verification and validation data, investigations, and change control information for technical reports related to the cleaning program.Track equipment and product qualification status. Participate in the development of appropriate testing strategies including swabbing location.Support the optimization of processes including manual and automated cleaning processes. Support the development of cleaning activities to ensure that the system’s validation state is maintained.Identify testing approach and cleaning swab sample locations on new equipment and/or for new products in alignment with the philosophy defined by the Cleaning Validation engineering team.Participate in the creation of policies, procedures, guidelines, and templates in the area of validation.Job Requirements:Bachelor Degree in Science or Engineering with 2-3 years of directly related experience in the pharmaceutical industry.PharmaLex is an Equal Opportunity Employer.

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