Validation Coordinator

Validation Coordinator Req ID #:  206075 Location: 

Charleston, SC, US, 29407 For 75 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 Microbial Solutions site located in Charleston, SC.  

Develop and execute validation plans for  equipment, and materials.  Perform routine and non-routine maintenance on equipment associated with validation. Perform diagnostic review of equipment to ensure that the equipment is operating as designed and within validated parameters. Communicate with equipment vendors to trouble shoot any operational issues. Assist in the training of departmental production employees on technical operational skills and SOPs.

The following are the job duties & responsibilities related to the Validation Coordinator: 

•    Assist in the validation of alternative materials

•    Perform reviews of validated materials and vendors

•    Review SCAR data to ensure compliance with internal standards

•    Assess suppliers capabilities, quality, and performance

•    Work closely with department personnel and vendors to select appropriate equipment for purchase when replacement or new equipment is required.

•    Work with vendors to become the subject matter expert (SME) for new equipment.

•    Author new SOPs and / or modify existing SOPs, Training Modules and BRFs as necessary to comply with validated parameters.

•    Assist in the implementation of new and / or changed SOPs, Training Modules, and BRFs.

•    Understand Quality Risk Management tools and terminology

•    Perform investigations related to validation

•    Author, execute and prepare validation protocols and final reports associated with equipment and instrumentation.

•    Author, execute and prepare validation protocols and final reports for computer systems associated with equipment. 

•    Order supplies as needed for equipment  validation. Serve as a knowledgeable resource for any production team member who needs assistance with equipment.

•    Coordinate the implementation of service improvements to equipment to prevent future malfunctions. 

•    Ensure all processes and equipment are validated in line with regulatory requirements.

•    Participate in planning/coordination of projects for departments as needed.

•    Provide training on new equipment.

•    May act as team leader for departmental projects.

•    Work with a cross functional team to complete various validation activities.  

•    Responsible for documentation as required by the company policy, cGMP and FDA.

•    Perform general housekeeping and adhere to safety procedures.

•    Perform all other related duties as assigned. Job Qualifications The following are the minimum qualifications related to the Validation Coordinator: 

•    Education: Bachelor’s Degree in Science, Electronics, or related discipline.

•    Experience:  1-3 years related experience and/or training.

•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

•    Certification/Licensure:  None.

•    Other:  Advanced computer and math literacy required.  Experience in regulated industry (pharmaceutical or bio tech) strongly preferred. Effective communication and interpersonal skills required

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

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 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. And in 2019, revenue increased to $2.62 billion.

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 ~85% of the drugs approved by the FDA in 2019.

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, 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 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: Charleston South Carolina

Nearest Secondary Market: South Carolina

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