Senior Validation Engineer
Charles River Laboratories International Inc (CRL)
Rockville, MD, US, 20850
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Provide oversight and implementation of validation activities associated with computerized systems and equipment 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 follow the Master Validation Plan and applicable CGMP regulations.
Key Responsibilities and Duties:
• Prepare validation deliverables for computerized systems and equipment, including Validation Plans, Requirement Specifications, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports • Coordinate and schedule system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent Re-qualification (RQ) protocols, if applicable, for new and in-use equipment to ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements. • Assist system SMEs in the preparation of test scripts comprising formal testing of functional system and regulatory requirements in conjunction with computerized system validation. • Oversee and/or perform test script execution • Work with Operations and Quality to assess risk and impact with respect to proposed changes within the facilities and validated processes. Participate in meetings associated with the scheduling of these activities to ensure minimal impact to existing operations. • Provide ongoing Qualification/Validation and other appropriate System Lifecycle training/education of staff. • Provide ongoing support of Data Integrity projects to identify and ensure the safeguarding of data in compliance with site procedures, regulatory requirements, and corporate policies. • Organize an efficient method to ensure all requirements of assigned validation deliverables are completed and that validation efforts are executed in a timely manner. • Participate in the development of corrective actions, as needed, for deficiencies that may be uncovered/observed during validation efforts regarding equipment, processes, test methods, facilities, computer software/systems, SOPs, and other related issues to ensure compliance with applicable regulatory requirements/guidelines, procedures, and policies. • Participate in the development of CAPA’s and assess the effectiveness of the corrective action. Schedule validation project team meetings to ensure project milestone schedules are maintained and deliverables satisfy requirements. • Assist, as needed, during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation. • Manage validation contractors, as needed. • Provide technical review of documents pre and post execution. • Perform all other related duties, as assigned.
• Bachelor’s degree or equivalent in a scientific, Engineering, IT discipline, or related field. • Preference given to candidates with a minimum of 5 years validation related experience in a pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of lab equipment/instrumentation, test method, process, and facility validation in a regulated environment. • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. • Must have excellent oral and written communication skills. Strong documentation development and technical writing skills are critical to this position. • Must have in-depth knowledge of accepted industry practices and regulatory requirements that govern computer system validation in the pharmaceutical industry. 21 CFR Parts 210, 211, 820, 11, EU Annex 11, and applicable ICH and FDA guidance's. • Leadership ability, project management, and facilitation skills required. Must be proficient with Microsoft Office software (Word, Excel, PowerPoint). Must have good interpersonal, organizational, and analytical skills.
The pay range for this position is $100,000 - $110,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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 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 OpportunityCharles 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 [email protected] This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.