Validation Engineer 1 (EG)

Validation Engineer 1 (EG) Req ID #:  210352 Location: 

Memphis, 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

  Job Summary  

We are seeking a Validation Engineer I to support our Cell Therapy Manufacturing Facility located in Memphis, TN. 

The Validation Engineer I supports the qualification/validation programs for equipment, instruments, and facility used in cellular manufacturing.  As a technical resource for a GMP regulated facility, The Validation Engineer assists primarily in the development and execution of verification/qualification/validation protocols of cell therapy manufacturing systems, ensuring equipment and facilities are operating in compliance with Charles River Laboratories and all applicable regulatory requirements. 

The following are responsibilities related to the Validation Engineer I position:

  Technical writing of qualification/validation protocols and summary reports for IQ/OQ and/or PQ of basic cell processing equipment such as incubators, centrifuges, freezers, etc. Technical writing of qualification/validation protocols and summary reports for IQ/OQ and/or PQ of lab instruments. Technical writing of media qualification and process performance qualification (PPQ/PV) protocols and reports. Execution of qualification/validation protocols for cell processing equipment, lab instruments, cleaning, process, shipping, test method and other validation activities as needed. Assist and contribute to the evaluation of non-conformances, exceptions, and/or deviations that could affect product safety and quality. Ensure all generated validation documentation meet all applicable regulatory requirements. May be required to work off-shift or weekends to support validation efforts. Assist in the training of newly hired Validation Associates as needed. Provide updates to Manager, Validations on validation activities. Work cooperatively with Manufacturing, Facilities, Materials Management, Quality Assurance, and other departments as necessary. Other duties as assigned by Supervisor, Manager or Director of Validation. Job Qualifications The following are minimum qualifications related to the Validation Engineer I position:

  B.S. in related field or a combination of at least 2-4 years of industry experience in cell processing equipment and facility validation. May consider less education and professional experience upon successful completion of Charles River’s internship program. Advanced technical writing skills. Minimum of 2 years of experience in Equipment, Instrument and Facility validation is preferred. Minimum of 2 years of experience working in a GxP regulated environment is preferred. Must demonstrate excellent problem-solving ability, technical writing skills, good communication skills, and teamwork. 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. Must be flexible and able to adapt to company growth and evolving responsibilities. Able to wear cleanroom/protective gowning and pass gown qualification. Ability to multi-task and manage multiple projects with shifting priorities in a fast-paced manufacturing environment.

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

About Biologics Testing Solutions

With 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 River

Charles 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 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.

Equal Employment Opportunity

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 crrecruitment_US@crl.com. 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 www.criver.com.

Nearest Major Market: Memphis

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