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Arrowhead Pharmaceuticals · 2 weeks ago

Associate Engineer, cGMP Computer Systems Validation

Verona, WI

Full-time

Onsite

Mid, Senior Level

$80K/yr - $95K/yr

5+ years exp

Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative drugs for intractable diseases. The Associate Engineer will provide validation and lifecycle support for computerized systems within a regulated Quality organization, serving as a subject matter expert and ensuring compliance with validation processes.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Provides Quality guidance for CSV efforts related to requirements engineering, system risk assessments, and data integrity assessments

Reviews and approves validation documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Functional Requirements Specifications, Testing Protocols, Requirements Trace Matrices, and Summary Reports

Serve as an SME for CSV and maintain knowledge and information in the Computer System Validation area of expertise

Review CSV documentation to ensure data integrity requirements are maintained

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 provide support for regulatory inspections and inspection readiness activities

Review and approve periodic reviews of system validation. Ensure appropriate remediation plans are determined for gaps identified during periodic reviews

Qualification

Computer System ValidationGMP regulationsGLP regulationsQuality certificationPharmaceutical experienceCollaborationDocumentation skillsCommunication skills

Required

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