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Senior Validation Engineer - Silver Spring, United States - Charles River Laboratories
Description
Location field must contain 'city, state' or a zip code to perform a radius search (e.g.,Denver, CO
or
City and state must be separated by a comma followed by a space (e.g.,
Houston, TX )
Charles River Laboratories
Senior Validation Engineer
in
Memphis ,
Tennessee
Senior Validation Engineer
Location:
Memphis, TN, US, 38118Memphis, TN, US, 38118
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 whichinclude 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 CAPAJob 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.
5-7 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 GxP Computerized Systems such as MasterControl, Blue Mountain Regulatory Asset Manager, LabVantage, and Metasys is preferred.
Knowledge of manufacturing processes and safety in GMP regulated facilities.
Efficient in Microsoft 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 RiverCharles River is an early-stage contract research organization (CRO).
We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities.
Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges.
Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.At Charles River, we are passionate about our role in improving the quality of people's lives.
Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.
We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected] .
This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit#J-18808-Ljbffr
