SR. SPECIALIST, CSA QUALITY

We are currently working with a mid-sized patient-focused cell and gene therapy company based in Columbus, OH. The organization aims to accelerating the creation and production of cutting-edge remedies in order to provide more patients with effective treatments.

This role will serve as technical subject matter expert for Computer Software Assurance (CSA) process, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools.

Qualifications:

• Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
• Minimum 8 years of experience in Computer Systems Validation (CSV), Computer Software Assurance (CSA), or Software Quality Assurance in a regulated (pharmaceutical/biotech preferred) environment.
• Strong knowledge of FDA regulations, including 21 CFR Part 11, Annex 11, EU GMP Chapter 4, MHRA Guidance, ALCOA++, Audit Trails, and GAMP 5 principles.
• Extensive experience authoring and reviewing validation documentation.
• Experience implementing and maintaining risk-based validation approaches.
• Strong technical knowledge of SaaS applications, cloud platforms, and infrastructure qualification principles.
• Experience on the Risk assessment approach to support the CSA.
• Familiarity with ITSM and Change Management processes (preferred in a GxP environment.)
• Hands-on experience working in validation lifecycle management tools, with preference for experience in Res_Q by Sware.

If you believe you'd compliment this role based on your Quality background in pharmaceuticals/biotechnology, please apply.