Validation Engineer I

Validation Engineer I Req ID #:  142991 Location: 

Memphis, TN, US, 38104 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 Engineer I for our Cognate BioServices site located in Memphis, TN.  

The following are responsibilities related to the Validation Engineer I:

Reporting to the Manager of Validation, the Validation Engineer supports the qualification/validation programs for equipment, instruments, and facility used in cellular manufacturing at Cognate BioServices, Inc. As a technical resource for GMP regulated facilities, the Validation Engineer assists primarily in the development and execution of verification/qualification/validation protocols of cell therapy manufacturing systems, ensuring equipment and facility are operating in compliance with Cognate BioServices and all applicable regulatory requirements. The Validation Engineer is expected to work cooperatively with Manufacturing, Facilities, Materials Management, Quality Assurance, and other departments as necessary.

ESSENTIAL DUTIES AND RESPONSIBILITIES

•Technical writing of qualification/validation protocols and summary reports for IQ/OQ and/or PQof basic cell processing equipment such as incubators, centrifuges, freezers, etc.

•Technical writing of qualification/validation protocols and summary reports for IQ/OQ and/or PQof 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 thatcould 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.

•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:

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS

• B.S. in related field or a combination of at least 3-5 years of industry experience in cell processing equipment and facility validation.

• Advanced technical writing skills.

• Minimum of 3 years of experience in Equipment, Instrument and Facility validation is preferred.

• Minimum of 3 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. 

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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