Job descriptionImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.” ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed. The Senior Computer Systems Validation Engineer role can be remote (approximately 70% off-site/30% El Segundo based) depending on the needs of the company. The Sr. CSV Engineer is responsible for compliance oversight of enterprise CSV projects as part of the IT team. This role is hands-on, highly cross-functional, and works closely with various business stakeholders to ensure GxP compliance. Supports validation of all Manufacturing, R&D, and Quality systems. Coordinates and/or supports delivery of compliance deliverables such as System Inventory, Quality Impact Assessments, Data Integrity Assessment, Risk Assessments, Gap Analysis, System Remediation, System Change Control and CAPA investigations/resolutions. Responsibilities:
- Oversee the execution of qualification/validation activities of new software implementations and maintenance of existing systems.
- Author, review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports).
- Perform risk assessments with functional teams to assess system risks and develop mitigation plans
- Update and/or create computer system related policies, procedures, templates, forms, etc.
- Provide input to GxP assessments for 21 CFR Part 11/Data Integrity requirements
- Review and approve computer system change controls, discrepancies, CAPAs
- Review and provide feedback to vendor validation documentations (validation plans, executed protocols, risk assessments, etc.)
- Works closely with the QA function to provide expertise in CSV compliance, manage identified issues, and support continuous improvement.
- Support inspection readiness programs and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable.
- Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.
- Minimum of a Bachelor's degree in Computer/Information Systems, Engineering, Science or equivalent technical discipline is required.
- Minimum of 5 years of experience working in biotech/pharmaceutical industry in Quality compliance or Computer System Validation role.
- Strong knowledge in 21 CFR Part 11, GAMP5, electronic record/electronic signature, and data integrity requirements, standards and guidelines.
- Strong background and understanding of FDA regulations.
- Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
- Experience in authoring/reviewing/approving validation documentation.
- Working knowledge of software development lifecycle (SDLC).
- Experience supporting enterprise software deployments and laboratory/manufacturing equipment and instruments (such as HPLC, MES, ERP, DMS, QMS, etc.)
- Excellent written and verbal communication skills with ability to work with cross-functional teams.
- Experience with vendor audits, quality agreements
- Ability to manage multiple projects
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