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** Reporting to the Manager Validation, the Validation Engineer II supports the qualification/validation programs for equipment, instruments, and facility used in cellular manufacturing at Charles River Laboratories. As a technical resource for GMP regulated facilities, the Validation Engineer II assists primarily in the development and execution of verification/qualification/validation protocols of cell therapy manufacturing systems, ensuring equipment and facility are operating in compliance with Charles River Laboratories and all applicable regulatory requirements. The Validation Engineer II is expected to work cooperatively with Manufacturing, Facilities, Materials Management, Quality Assurance, and other departments as necessary. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Responsible for Validation (CQV) deliverables for the facility, utilities, systems, and equipment (FUSE) used in cellular manufacturing. * Responsible for development of documents which include but are not limited to; User Requirement Specifications, System Impact Assessments (SIA, CSIA) Configuration Specifications, Validation Plans, IOPQ protocols, summary reports, and traceability matrix that meet regulatory and industry standard guidelines * Ensures adequate measures are in place to achieve and maintain GxP compliance through all Validation lifecycle stages from inception to retirement. * Manage implementation of critical systems and equipment that may also incorporate computerized systems. * Technical writing of qualification/validation protocols and summary reports for IQ/OQ and/or PQ of basic cell processing equipment such as incubators, centrifuges, freezers, etc. * Technical writing of qualification/validation protocols and summary reports for IQ/OQ and/or PQ of lab instruments. * Technical writing of media qualification and process performance qualification (PPQ/PV) protocols and reports. * Execution of qualification/validation protocols for cell processing equipment, lab instruments, cleaning, process, shipping, test method and other validation activities as needed. * Assist and contribute to the evaluation of non-conformances, exceptions, and/or deviations that could affect product safety and quality. * Ensure all generated validation documentation meet all applicable regulatory requirements. * Assist in the training of newly hired Validation Engineer I's as needed. * Provide updates to Manager, Validations on validation activities. * Perform all other related duties as assigned. **Job Qualifications** * B.S. in related field or a combination of at least 3-5 years of industry experience in cell processing equipment and facility validation. * At least 3-5 years of experience in Equipment, Instrument and Facility validation is preferred. * At least 3-5 years of experience working in a GxP regulated environment is preferred. * An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. * Must demonstrate excellent problem solving ability, technical writing skills, good communication skills, and teamwork. * Knowledge of manufacturing processes and safety in GMP regulated facilities Pharmaceutical/Medical Device/Biotechnology. * Knowledge in operating Kaye Validator system and data trace equipment preferred. * Knowledge of GxP Computerized Systems such as MasterControl™, Blue Mountain Regulatory Asset Manager®, LabVantage®, and Metasys® is preferred. * Knowledge of manufacturing processes and safety in GMP regulated facilities. * Efficient in Microsoft® Office and other office software as applicable. * May be required to work off-shift or weekends to support validation efforts. * Must be flexible and able to adapt to company growth and evolving responsibilities. * Able to wear cleanroom/protective gowning and pass gown qualification. * Ability to multi-task and manage multiple projects with shifting priorities in a fast-paced * manufacturing environment * Advanced technical writing skills. The pay range for this position is $106,000 - $117.200. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **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. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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. 226459