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Senior Validation Engineer
Location:
Memphis, TN
Description:
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well:being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary Sr. Validation Engineer to support our Cell Therapy Manufacturing facility located in Memphis, TN. The Sr. Engineer will have the experience to be functional lead responsible for Validation (CQV) deliverables for the facility, utilities, systems and equipment (FUSE). Will also be responsible for development and execution of CQV deliverables through formal assessment, protocol development, testing, and reporting in compliance with Charles River Laboratories and all applicable regulatory requirements. : Responsible for Validation (CQV) deliverables for the facility, utilities, systems, and equipment (FUSE) used in cellular manufacturing.: Responsible for development of documents which include but are not limited to; User Requirement Specifications, System Impact Assessments (SIA, CSIA) Configuration Specifications, Validation Plans, IOPQ protocols, summary reports, and traceability matrix that meet regulatory and industry standard guidelines: Ensures adequate measures are in place to achieve and maintain GxP compliance through all Validation lifecycle stages from inception to retirement.: Manage implementation of critical systems and equipment that may also incorporate computerized systems.: Advanced understanding and experience with regulations and guidelines such as FDA, EU, ISPE, ISO, NSF, 21 CFR Part 11, and GAMP5.: Advanced understanding of the Quality Management System, Change Control, and CAPA Job Qualifications:Minimum of BA/BS degree in Science or Engineering discipline, or related field with appropriate experience, required.:Bachelor's degree in Computer Science/Engineering or equivalent experience, preferred. : 2+ years' experience in a GxP cleanroom environment working with facility, utilities, systems, and equipment (FUSE) used in Cell Therapy Manufacturing or equivalent industry experience. :Knowledge of manufacturing processes and safety in GMP regulated facilities Pharmaceutical/Medical Device/Biotechnology.:Knowledge in operating Kaye Validator system and data trace equipment preferred.:Knowledge of manufacturing processes and safety in GMP regulated facilities.:Efficient in Microsoft(R) Office and other office software as applicable.:May be required to work off:shift or weekends to support validation efforts. The pay range for this position is 100,000 : 110,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Biologics Testing SolutionsWith more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand:alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team. About Charles Ri
Posted:
May 7 on Tip Top Job
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More About this Listing: Senior Validation Engineer
Senior Validation Engineer is a Engineering Validation Engineer Job located in Memphis TN. Find other listings like Senior Validation Engineer by searching Oodle for Engineering Validation Engineer Jobs.
Senior Validation Engineer is a Engineering Validation Engineer Job located in Memphis TN. Find other listings like Senior Validation Engineer by searching Oodle for Engineering Validation Engineer Jobs.