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Validation Engineer 2

Company: Charles River Laboratories
Location: Memphis
Posted on: June 25, 2022

Job Description:

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 2 for our Cell Therapy Manufacturing Facility located Memphis, TN.

The Validation Engineer 2 will be the functional lead responsible for development and execution of utilities, systems, and equipment (FUSE) Validation (CQV) for our cGMP Cell Therapy Manufacturing Facility located in Memphis, TN. As a technical resource for GMP regulated facilities, the Validation Engineer 2 will have the opportunity to work on deliverables for BMS, clean utilities, cleanroom suites, Cell and Gene Therapy manufacturing equipment and systems, and complex QC instruments. You will also be responsible for development and execution of CQV deliverables through formal assessment, protocol development, testing, and reporting; providing a high degree of assurance ensuring that critical GxP systems meet design criteria and user specifications. The Validation Engineer 2 is expected to ensure adequate measures are in place to achieve and maintain GxP compliance through all Validation lifecycle stages from inception to retirement.

The following are responsibilities related to the Validation Engineer 2:

  • Lead efforts to generate documentation which meets regulatory and industry standard guidelines in a timely and efficient manner in a challenging and fast-moving environment. These documents include but are not limited to; User Requirement Specifications, Functional Specifications, Validation Plans, design / configuration specifications, traceability matrix, design qualification, IOPQ protocols and summary reports, supplier assessments, risk assessments, 21 CFR Part 11 assessments, and overall critical GxP lifecycle management.
  • Manage implementation of critical systems and equipment that may also incorporate computerized systems.
  • Advanced understanding of the authoring of protocols, Validation Summary Reports and associated documents.
  • Efficient in Microsoft - Office and other software as applicable.
  • 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
  • Be flexible, proficient in technical writing, strong interpersonal and communication skills.
  • Awareness of OSHA and safety programs.
  • May be required to work off-shift or weekends to support validation efforts.
  • Able to work well in a team-oriented environment.
  • Demonstrated relationship, team building skills and able to encounter challenges.Job QualificationsThe following are the minimum qualifications related to the Validation Engineer 2 position:

    • Bachelor of Science degree in Electrical, Mechanical, Chemical Engineering or Equivalent Validation Engineer work experience may be considered, in lieu of a degree.
    • Minimum of 3 years of CQV experience in a GxP cleanroom environment working with critical systems and equipment.
    • Experience with process performance qualification (PV/PQ/PPQ) preferred.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. Our main priority is the wellbeing, health, and safety of our people. We require 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 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.

Keywords: Charles River Laboratories, Memphis , Validation Engineer 2, Engineering , Memphis, Tennessee

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