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Validation Coordinator

Req ID #:  42391

Malvern, PA, US, 19355

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.

Job Summary


We are seeking a Validation Coordinator for our Biologics Testing Solutions site located in Malvern, PA.


The following are minimum requirements related to the Validation Coordinator position.




Responsible for equipment validation, including with assisting with department's purchase of equipment, working with departments to establish IQ, OQ and PQ protocol requirements, and coordinating these qualification steps. Participate in the review of validation activities contracted to external vendors and ensure the equipment database is maintained and current. Participate in all aspects of assay validation, facility validation and process validation as it pertains to validation services operational support.





  • Manage, develop, and implement validation test procedures to ensure that facilities, equipment, and processes meet appropriate regulatory validation requirements, internal company standards and industry current practices.
  • Oversee and review validation area processes and procedures, making recommendations for changes and/or improvements.
  • Interact with laboratory supervisors/managers, customers, and suppliers/vendors as necessary to support validation functions
  • Ensure the site equipment database is maintained and current
  • Participate in Computerized System Validation activities
  • Coordinate the establishment of task specific validation teams
  • Coordinate and verify the completion of validation tasks according to SOPs




  • Education: Bachelor's degree in science or engineering (BA/BS)
  • Experience:  Minimum of two years experience working in a laboratory or project team.
  • Certification/Licensure: None
  • Other: Regulatory compliance in cGMP environment, excellent communication skills, excellent computer skills preferred


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 13,000 employees within 80 facilities in 23 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 in 2017.


For more information, please visit


Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet


Nearest Major Market: Philadelphia

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