CSV Validation Manager

Company: Regenxbio Inc.
Location: Rockville
Posted on: November 8, 2024

Job Description:

Who we areREGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.The CSV Validation Manager will be responsible for managing all aspects of the validation program/team. This position will oversee qualifying GxP equipment including, but not limited to, GxP analytical equipment, controlled temperature units, GMP manufacturing equipment, and GxP computer systems. In addition, the Validation Manager will need to maintain up to date knowledge of validation requirements, practices, and procedures and instruct others participating in validation activities.What you'll be doing

• Manage the development, collaboration, and review of validation deliverables for equipment and computer systems used in GxP laboratories and manufacturing.
• Oversee the timely completion of all validation documentation, including coordination of contractor activities.
• Interact with other departments to facilitate validation activities as needed.
• Manage the creation and execution of validation protocols in accordance with SOPs and industry standards.
• Initiate, own, and review change controls for validated laboratory, production, and other GxP related systems.
• Ensure all validation documents achieve the goal of traceability and risk acceptance.
• Oversee troubleshooting and investigations of validated systems.
• Lead periodic reviews of systems to ensure they are maintained in a validated state.
• Ensure compliance with all applicable GxP regulations as well as appropriate SOPs.
• Lead development and continuous improvement initiatives.
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships, and using clear communication to meet shared objectives.What we're looking for
  • Minimum BA / BS or relevant work experience in engineering or science.
  • Minimum of 5 years of validation experience or 3 years of validation experience and graduate degree required.
  • Working knowledge of cGMP, GLP, 21CFR11, and industry best practices.
  • Working knowledge of ASTM E2500 and GAMP 5.
  • Strong communication (oral and written) and interpersonal skills.
  • Ability and willingness to work in a fast-paced environment.
  • Preferred but not required:
  • Experience in pharmaceutical GxP operations.
  • Experience with electronic validation systems.
  • Experience with buildout of a manufacturing facility and moving laboratory spaces.
  • Experience with computer systems validation including Document and Quality Management Systems (eDMS and QMS), Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), and Process Control Systems (PCS).
  • Computer system data mapping experience related to data integrity.Why Should You Apply?By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients. We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.
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Keywords: Regenxbio Inc., Baltimore , CSV Validation Manager, Executive , Rockville, Maryland