Validation Engineer Computer System Validation - Operations

Validation Engineer Computer System Validation - Operations Req ID #:  86561 Location: 

Wayne, PA, US, 19087 For 70 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 Engineer, Computer System Validation - Operations for our Biologics Testing Solutions site located in Wayne, PA.

Provide oversight and implementation of validation activities associated with computerized systems to ensure compliance with applicable Current Good Manufacturing Practice (CGMP) regulations, Corporate policies, and site Standard Operating Procedures (SOP's). Work closely with the operations and quality departments to develop validation deliverables, ensuring fit for purpose and testing requirements that are defined, and are in compliance with the Master Validation Plan and applicable CGMP regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Collaborate with Operations staff to drive change, replacing manual methodologies with technology to streamline and automate laboratory processes. Prepare validation deliverables for computerized systems, including Validation Plans, Requirements Specification, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11 and Annex-11. Provide support for Data Integrity projects to identify and ensure the safeguarding of data in compliance with site procedures, regulatory requirements, and corporate policies. Participate in the development of corrective actions as needed for deficiencies that may be uncovered/observed during validation efforts in regard to equipment, processes, test methods, facilities, computer software/systems, SOPs, and other related issues in order to assure compliance with applicable regulatory requirements/guidelines, procedures, and policies.

MINIMUM QUALIFICATIONS: Bachelor's degree (B.A./B.S.) or equivalent in a scientific, Engineering, IT discipline or related field. Preference given to candidates with a minimum of 5 to 7 years computerized system validation related experience in a pharmaceutical, biotechnology and/or biomedical industry. Knowledge of lab equipment/instrumentation, test method, process, and facility validation in a regulated environment. Leadership ability, project management, and facilitation skills required. Must be proficient with office software (word processing, spreadsheets, PowerPoint). Must have good wiritten, verbal communication, and analytical skills.

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 17,000 employees within 90 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 - M/F/Disabled/Vet.

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: Philadelphia

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