Validation Engineer II
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
Validation Engineer II Req ID #: 174732 Location:
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 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 Qualifications The 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.
• 3 years of CQV experience in a GxP cleanroom environment working with critical systems and equipment preferred.
• 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.
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 ([email protected]) 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.
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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.
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, 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 www.criver.com.
Nearest Major Market: Memphis
Job Segment: Facilities, Pharmaceutical, Recruiting, Manufacturing Engineer, Testing, Operations, Science, Human Resources, Engineering, Technology
Similar CRA jobs
Systems Engineer Co-Op - Fall 2021
Senior Quality & Test Engineer
Site Support Engineer
Software Engineer (Remote)
Software Quality Assurance Engineer (Remote/WFH)
Systems Engineer LIMS
Associate Scientist, Validation Science
Software Test Engineer
Senior Test Engineer
Laboratory Systems Validation Specialist
Product QA Engineer
Sales Engineer - Quality
Mechanical Engineering - Technical/Scientific
Senior Backend Engineer
Automation System Engineer
Mid-Senior DevOps Engineer
Data & DevOps Engineer