Senior Engineer, Quality Engineering

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing 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. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved in disease. Arrowhead’s RNAi-based therapeutics leverage the natural pathway of gene silencing, enabling the potential to address conditions across virtually any therapeutic area, including targets not addressable by small molecules and biologics.

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

About the role

This position within the Quality Assurance department will support ongoing programs for commercialization at Arrowhead. A key function involves providing leadership and guidance in principles of qualification, cleaning validation, process validation, and continued process verification (CPV) in support of commercialization activities. The role will also support the continued development and maintenance of quality systems for Good Manufacturing Practices (GMP).

Responsibilities

• Serve as the Quality Assurance subject matter expert on qualification, cleaning validation, process validation, and CPV, including providing guidance, review, and approval of activities such as system requirements engineering, process design, risk assessments, and supporting validation documentation.
• Support the establishment of documentation and templates for cleaning and process validation, including risk assessments for product-contact equipment, process, materials, and critical quality attributes (CQAs) and parameter classification.
• Draft, review, and approve procedures in support of quality systems for qualification and validation.
• Mentor Quality Assurance members in Quality Engineering functions (e.g., department procedures, audits, cleaning validation, equipment qualification, process validation, validation assessments, CPV).
• Work with cross-functional teams to review and approve internal and vendor-generated data and documentation in support of validation, qualification, and commissioning activities.
• Provide support for the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs related to validation activities and assessments.
• Support the development and implementation of periodic reviews for validated systems/processes, including the establishment of CPV procedures for commercial manufacturing.
• Provide secondary review of registration batches to evaluate and assess systemic issues.
• Prepare documentation and provide support for internal and external audits.
• Perform other duties consistent with the position as assigned.

Requirements

• A bachelor’s degree or higher in a science field.
• 15+ years of experience working within cGMP-regulated manufacturing, specifically in validation-related roles in manufacturing and/or quality (bachelor’s degree required for this experience level).
• Working knowledge of GMP regulations (21 CFR Part 210/211, EU Annex 11/15, ICH Q7, and 21 CFR Part 11).
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize work tasks with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Competent knowledge and ability to use Microsoft Word and Excel.

Preferred Qualifications

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

Pay

Wisconsin pay range: $125,000 USD - $140,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.