Computer Validation Engineer II
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
Job Summary
Responsible for supporting manufacturing operations including, but not limited to, equipment and softward and for assisting in the selection and defining specifications of such equipment and software. Responsible for maintaining all documentation pertaining to validation activities. Serve as an information resource for validation team members, contractors, and vendors.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for full lifecycle of computer system validation projects including deliverables for the facility, utilities, systems, and equipment • Responsible for writing and developing 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 • Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate and site quality management system and current industry practice • Ensures adequate measures are in place to achieve and maintain GxP compliance through all Validation lifecycle stages from inception to retirement • Write or assist in the writing of SOPs for the Validation team • Maintain validation documentation and files including the Master Validation Plan in defined locations per approved procedures • Ensure the Systems Inventory is up to date at all times • Manage implementation of critical systems and equipment that may also incorporate computerized systems • Manage cross functional teams involved in the validation project deliverables such as project management, IT and other department leaders and vendors • Provide project updates and input into established project documentation • Effectively communicate project expectations to team members and stakeholders in a timely and clear manger • Report any non-compliances of Quality Management System with respect to validation to the Senior Management • Idenfity, plan, and schedule project timelines and milesstones using appropriate tools • Develop and implement solutions to validation issues • Present validation systems program during internal and external audits • Perform all other related duties as assigned.
Job Qualifications
• Bachelor’s degree (BA/BS) degree or equivalent in computer science, science or related discipline • 5-7 years’ experience in a GxP environment working with facility, utilities, systems, and equipment (FUSE) used in cellular manufacturing or equivalent industry experience. • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed • Test or validation certification desired • Comprehensive knowledge of regulatory requirements including GxP, 21 CFR Part 11, Annex 11, cGMP, and ISPE GAMP5. • Awareness of OSHA and safety programs. • Demonstrated relationship, team building skills and able to encounter challenges. • Be flexible, proficient in technical writing, strong interpersonal and communication skills. • Efficient in Microsoft® Office and other software as applicable.
Compensation Data
The pay range for this position is $90,000 - $98,000. 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 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 [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
Job posted: 2024-06-06
