For nearly 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
Full-time Validation scientist is required to operate under the Technical Services Department. Validation scientist is responsible for organisation, execution and documentation of all activities associated with the Celsis complete package within the Technical Services Celsis laboratory.
Essential DUTIES & RESPONSIBILITIES:
- Determine methods and procedures on new assignments (assist the Lab Management in creating customer protocols for Celsis Complete packages).
- Assist Management in projects such as Implementation or new processes/ Product Validation/ Process validation.
- Perform laboratory activities necessary to isolate, grow and maintain cultures of bacteria.
- Ensuring they are up to date on all training new Celsis technology and regulatory requirements for processes associated with Celsis complete within the Technical Services Laboratory.
- To be the designated person/ SME who will pass the training on to the remaining lab members.
- Perform training with new analysts (theory and practical) on all different Celsis kit types and assist with the documentation of all training records in accordance with the site GDP.
- Collaborate with inventory check of laboratory consumables and assist with general housekeeping of the laboratory, performing equipment maintenance and scheduling instrument calibrations or qualifications.
- Ensure adherence to pertinent regulatory requirements (cGMP, FDA, ISO) and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
- Assist management with development and revision of departmental standard operating procedures and qualification documents.
- Assist management with reporting of any quality issues through LIRs, OOS, Dev and CAPAs.
- Assist management in managing TAT for projects within the Celsis and Endosafe lab and ensure that progression of all projects is communicated to management during the weekly team meetings.
- Perform all other related duties as assigned.
Job Qualifications
Education: Degree in Microbiology, Biology or a related discipline.
Experience:
Demonstrable track record of established experience in cGMP pharmaceutical microbiology environment is essential. In particular the use of Sterility and Bioburden testing and validation. Experience in the use of Celsis technology is preferred, however full training will be provided.
Other
Awareness of regulatory requirements associated with alternative method validation for sterility testing.
Knowledge of windows-based programs such as word and excel and a minimum knowledge of algebra.
Comprehensive knowledge of all Celsis kit types is desirable.
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 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.
