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Manager CSV Automation

Charles River Laboratories International Inc (CRL)

Memphis, TN, US, 38118

Job Summary

Transformational advocate and champion responsible for strategy and implementation of CSV and automation within CGMP laboratories. Responsible for overseeing multisite CSV activities and supporting automated laboratory workflows within existing, and newly built laboratories. Lead the CSV/Automation department and work closely with individuals within the operations and quality departments to develop validation deliverables, ensuring fit for purpose and testing requirements that are defined, and are in compliance with the Master Validation Plan and applicable CGMP regulations.

  • Lead a group of CSV validation and Automation Engineers to ensure timely completion of projects with the PA Biologics facilities.
  • Engage with scientists across multiple departments to design and implement CSV & automation solutions, with the goal to increase efficiencies, capacity, turnaround times, and reduce opportunities for human error.
  • Lead collaborations and innovative efforts to convert manual assays to automated platforms.
  • Install, test, and validate new automation systems, and adapt existing automation systems to ensure they meet scientific needs, user functionality, and regulatory requirements.
  • Be a hands-on guide to support end users when faced with technical issues and provide comprehensive training and documentation to enable the end user to use the automation platform autonomously.
  • Prepare validation deliverables for computerized systems as required, including Validation Plans, Requirements Specification, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports.
  • Coordinate and schedule system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent Re-Qualification (RQ) protocols if applicable for new and in-use equipment to ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements.

Job Qualifications

  • Education:Bachelor's degree (B.A./B.S.) or equivalent in a scientific, Engineering, IT discipline or related field.
  • Experience: Minimum of 7 to 10 years laboratory automation and computerized system validation related experience in a CGMP pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of lab equipment/instrumentation, test method, process, and facility validation in a regulated environment.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Compensation Data

The pay range for this position is $120,000 - $140,000.  Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location. 

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 20,000 employees within 110 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 86% of the drugs approved by the FDA in 2021.

Equal Employment OpportunityCharles 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, or 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.

Job posted: 2023-06-06

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