Job Description

Associate Engineer, Computer Systems Validation, Quality Engineering

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. Arrowheads 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 involved with disease. The depth and versatility of our RNAi technologies enable us to 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, with a pipeline including disease targets in the liver and lung and a promising set of preclinical candidates.

Our corporate headquarters are in Pasadena, CA, with research and development teams in Madison, WI, and San Diego, CA. Our employees are nimble, science-driven innovators collaborating to bring new therapies to patients in need.

The Position

This role works within the cGMP, GLP, and GCP-regulated Quality organization to support validation and lifecycle management of computerized systems, software, and IT infrastructure that are 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 throughout the system lifecycle. They will serve as a subject matter expert providing compliance leadership and oversight for CSV projects, collaborating with business partners to maintain and improve validation processes.

Responsibilities

• Provide Quality guidance for CSV efforts, including requirements engineering, system risk assessments, and data integrity assessments.
• Review and approve validation documentation such as 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 expertise in computer system validation.
• Review CSV documentation to ensure data integrity requirements are met.
• Review and approve discrepancies or deviations during qualification or validation activities.
• Review, assess, and approve change controls for computerized systems.
• Coordinate validation activities with stakeholders.
• Provide direction to validation contractors if required.
• Support audits by communicating CSV approaches.
• Prepare documentation and support regulatory inspections and readiness activities.
• Review and approve periodic validation reviews and ensure remediation plans are implemented for gaps identified.

Requirements

• Bachelors degree in an applicable science field.
• Additional certification such as CQA or CQMP is preferred.
• Minimum of 5 years of experience in a pharmaceutical, biotech, contract manufacturing, or research organization, with responsibilities related to computerized system, equipment, or instrument qualification.
• Working knowledge of GMP and/or GLP regulations from FDA, EU, and ICH.

Preferred

• Experience with electronic document management systems in a regulated environment.

$80,000 $95,000 USD
Arrowhead offers competitive salaries and excellent benefits. All applicants must have authorization to work in the US.
#J-18808-Ljbffr Arrowhead Pharmaceuticals, Inc

Job Tags

Contract work, For contractors,

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