Associate Engineer, cGMP Computer Systems Validation

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

This position will work within the cGMP, GLP, and GCP-regulated Quality organization to provide validation and lifecycle support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced, and/or modified. The in cumbent will be responsible for guiding, generating, reviewing, and/or approving system assessments, test scripts, change controls, process improvements, and data integrity and governance at the applicable points of the system lifecycle. The position will serve as the subject matter expert to provide compliance leadership and oversight for CSV projects, collaborating with business partners to maintain and improve computer system validation processes.

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.

Requirements:

• 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.

Preferred:

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

Wisconsin pay range
$80,000—$95,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

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

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