Associate Engineer, cGMP Computer Systems Validation

The Position

Arrowhead is a clinical stage biopharmaceutical company that develops medicines that treat intractable genetic diseases by silencing the genes that cause them. We are looking for a System Validation Engineer to work within the cGMP, GLP, and GCP‑regulated Quality organization. The successful candidate will provide validation and lifecycle support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced, or modified.

The incumbent will guide, generate, review, and approve system assessments, test scripts, change controls, process improvements, and data integrity and governance at the applicable points of the system lifecycle. The role also serves as the subject‑matter expert for CSV projects, collaborating with business partners to maintain and improve computer system validation processes.

• Provide quality guidance for CSV efforts related to requirements engineering, system risk assessments, and data integrity assessments.
• Review and approve validation documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Functional Requirements Specifications, Testing Protocols, Requirements Traceability Matrices, and Summary Reports.
• Serve as an SME for CSV and maintain up‑to‑date knowledge in the Computer System Validation domain.
• Review CSV documentation to ensure data integrity requirements are met.
• Review and approve discrepancies/deviations encountered during qualification/validation activities.
• Review, assess, and approve computerized system change controls.
• Coordinate validation activities with key stakeholders.
• Provide direction to validation contractors (if required).
• Communicate CSV approach in support of audits.
• Prepare documentation and support regulatory inspections and inspection readiness activities.
• Review and approve periodic reviews of system validation and determine remediation plans for identified gaps.

• Bachelor’s degree in an applicable science field.
• Additional quality‑related certification desired (CQA, CQMP).
• Minimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization with expanding responsibilities related to computerized system, equipment, and/or instrument qualification.
• Working knowledge of overall GMP and/or GLP FDA, EU, and ICH regulations.

• Prior experience with an electronic document management system in a regulated environment.

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.