Discovery Solutions seeks applicants for a permanent position with one of our clients, a biotechnology company developing cell and immunotherapy products designed to strengthen each patient’s immune system and potentially outsmart disease and eliminate cancerous or infected cells.
Los Angeles, CA
This company develops cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.
The Computer Systems Validation 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.
- 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.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in Information Systems, Engineering, Science, or similar technical discipline required.
- Minimum 2-5 years of experience working in the Biotech/Pharmaceutical industry in Quality Compliance or Computer System Validation roles.
- 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
The employer requires a mandatory vaccination 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. The employer may also mandate that its employees receive vaccineboosters, and all accommodation laws will be followed.