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
- Acts as a Subject Matter Expert for CSV on processes, procedures, and systems.
- Identifies and initiates areas for continuous improvement applicable to CSV processes.
- Responsible for development and execution of the Computerized System Validation (CSV) deliverables for enterprises systems, control systems, complex instruments, and validated spreadsheets within the facility.
- Responsible for development and execution of CSV deliverables through formal assessment, protocol development, testing, and reporting; providing a high degree of assurance that critical GxP computerized systems meet design criteria/specifications for intended use and perform as intended.
- Ensures adequate measures are in place to achieve and maintain GxP compliance through all lifecycle stages from inception to retirement.
- 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 Requirement Specifications, Validation Plans, design / configuration specifications, traceability matrix, design qualification, UAT, IOPQ protocols and summary reports, regression testing, data migration testing, supplier assessments, risk assessments, 21 CFR Part 11 assessments, as well as manage the site computerized systems inventory and overall critical GxP computer system lifecycle management; including Change Control and Periodic Review.
- Maintain awareness of current OSHA and safety programs.
Job Qualifications
- Bachelor’s degree in Science, Engineering, or Computer Science discipline preferred
- 5+ years’ experience in a GxP environment working with critical computerized system validation required
- May be required to work off-shift or weekends to support validation efforts.
- Advanced understanding of the authoring of protocols, Validation Summary Reports and associated documents.
- Advanced understanding and experience with CSV regulations and guidelines such as GDP, FDA; 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5.
- Advanced understanding of the Quality Management System, Change Control, and CAPA
Compensation Data
The pay range for this position is $104,000 – $136,000. 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 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.