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
Supervise the implementation and validation of Computerized System Validation (CSV) used in cellular manufacturing as part of Cognate’s global CMO business. Supervise a team of Computer Validation Engineers to establish and maintain a validated state of cell based manufacturing within the Memphis site and coordinate technology transfer to/from other sites as needed. Support manufacturing to satisfy the quality and process validation requirements for existing products in a rapid growth environment as well as participate in the development and validation of new products, as needed. This position will also serve as a technical resource to improve product quality, reliability, and process capability. The position requires exceptionally strong communication, interpersonal and project management skills to effectively coordinate activities and achieve goals.
This position reports onsite to the facility.
- Assess new and existing CSV processes, procedures, and systems
- Develop and implement strategy for CSV (UAT IQ/OQ/PQ), enterprise systems, complex instruments, and spreadsheet validation.
- Perform functional and process risk assessments in conjunction with Quality and Operations subject matter experts.
- Oversee development and execution of validation protocols and review objective evidence for inclusion in validation reports.
- Supervise documentation and resolution of exceptions and variances that occur during validation.
- Work with Quality, Manufacturing, Regulatory, IT, and subject matter experts to prepare for FDA and other agency audits.
Job Qualifications
- Bachelor’s degree in Computer Science, Engineering, or related science field preferred
- At least 5 years’ experience in the biotech/pharmaceutical industry in validation, quality management, process controls, and continuous improvement in an FDA-regulated environment.
- Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5 in a manufacturing setting.
- Demonstrated application of FMEA, Risk Analysis, Validation principles, guidelines and industry best practice.
- Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment.
- Ability to lead a team of validation associates to prioritize and manage multiple projects across several product lines.
- Ability to supervise consultants and set expectations for the quality and timeliness of their deliverables.
- Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non-technical audience.
Advanced understanding of the Quality Management System, Change Control, and CAPA
Compensation Data
The pay range for this position is $83,000 – $116,700. 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.