Validation Specialist

Req ID #:  143011
Location: 

Memphis, TN, US, 38118 Memphis, TN, US, 38118

For 70 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 Specialist for our Cognate BioServices site located in Memphis, TN.  

 

The following are responsibilities related to the Validation Specialist:

Reporting to the Director of Validation the Validation Specialist supports the qualification/validation programs for equipment, instruments, and facility used in cellular manufacturing at Cognate BioServices, Inc. Activities will include the creation and execution of protocols as well as writing final reports in compliance with all applicable regulatory requirements. This position is expected to work cooperatively with Manufacturing, Facilities, Materials Management, and other members of the Quality department.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

•Execution of equipment qualification/validation protocols.

•Execution of instrument qualification/validation protocols.

•Organization and tracking of validation documentation.

•Technical writing of equipment verification summary reports.

•Assist in the evaluation of non-conformances, exceptions, and/or deviations that could affect product safety and quality.

•Support additional equipment, instrument, facility, and other validation activities as needed.

•May be required to work off-shift or weekends to support validation efforts.

•Provide updates to Manager regarding validation or validation activities.

•Other duties as assigned by Management.

 

Job Qualifications

 

The following are minimum qualifications related to the Validation Specialist position:

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS
 

•B.S. in a related field or a combination of 2 years related experience in the Pharmaceutical,Medical Device or Biotechnology industries is preferred.
•Knowledge in regulatory expectations for validation activities, program and documentation.
•Knowledge of cGMP and regulatory requirements for equipment and facility qualification in thebiopharma industry.
•Knowledge in operating Kaye Validator system and data trace equipment preferred.
•Knowledge of GxP Computerized Systems such as MasterControl™, Blue Mountain RegulatoryAsset Manager®, LabVantage®, and Metasys® is preferred.
•Must demonstrate problem solving ability, technical writing skills, good communication skills, andteamwork.
•Knowledge of manufacturing processes and safety in GMP regulated facilities -Pharmaceutical/Medical Device
•Efficient in Microsoft® Office and other office software as applicable.
•Must be flexible and able to adapt to company growth and evolving responsibilities.
•Ability to multitask and manage multiple projects with shifting priorities in a fast-pacedmanufacturing 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. 


Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

About Cognate BioServices
Cognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.


We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.


Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.


For more information, visit www.cognatebioservices.com 


Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.


 
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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