Senior Engineer, Quality Engineering

Socket.dev; Verona (WI); On-site; USD 125,000 - 140,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in the United States seeks a senior Quality Assurance professional to lead qualification, cleaning validation, and process validation activities in support of commercialization.

The role requires deep GMP/CGMP expertise, risk assessment, and coordination with various internal departments to ensure validated systems meet regulatory expectations. The candidate will mentor QA staff, review documentation, and support audits and CAPA processes.

Qualifications

• Bachelor’s degree or higher in a science field.
• 15+ years of experience in cGMP-regulated manufacturing, specifically in validation-related roles.
• GMP regulations knowledge: 21CFR Part 210/211, EU Annex 11/15, ICH Q7, 21CFR Part 11.
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize with minimal supervision.
• Strong interpersonal, verbal, and written communication skills.
• Proficient with Microsoft Word and Excel; familiarity with electronic document management systems is a plus.

Responsibilities

• Serve as QA SME on qualification, cleaning validation, process validation and CPV.
• Support documentation and templates including risk assessments and parameter classification.
• Draft, review, and approve procedures for quality systems in qualification and validation.
• Mentor QA team in quality engineering functions and audits.
• Review and approve internal/vendor data for validation, qualification, and commissioning.
• Support deviations, change controls, and CAPAs related to validation activities.
• Develop CPV procedures for commercial manufacturing and periodic reviews.
• Provide cross-functional support for audits and regulatory inspections.

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 within the Quality Assurance department will support ongoing programs for commercialization at Arrowhead. A key function of the position will involve providing leadership and guidance in principles of qualification, cleaning validation, process validation and continued process verification (CPV) in support of commercialization activities at Arrowhead. Generally, the position will support continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. Functions of this position will include serving as the Quality Assurance subject matter expert in qualification/validation, cross-functional interaction with internal departments to establish and/or update associated procedures/processes, review/approval of product lifecycle and validation documentation, performing validation assessment of changes and deviations for GMP systems and processes.

Responsibilities

• Serve as the Quality Assurance subject matter expert on qualification, cleaning validation, process validation and CPV. This includes providing guidance, review, and approval of activities such as system requirements engineering, process design, risk assessments, and supporting validation documentation.
• For cleaning and process validation, provide support in establishment of supporting documentation and templates including risk assessments (for product-contact equipment, process, materials, and CQAs) and parameter classification.
• Draft, review, and approve procedures in support of quality systems for qualification and validation.
• Serve as a resource to mentor Quality Assurance members in Quality Engineering functions (e.g., department procedures, audits, cleaning validation, equipment qualification, process validation, validation assessments, CPV, etc.).
• Work with cross-functional teams in the review and approval of 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 as related to validation activities and assessments.
• Support the development and implementation of periodic reviews for validated systems/processes including establishment of CPV procedures for commercial manufacturing.
• Provide secondary review of registration batches to evaluate and assess any systemic issues.
• Prepare documentation and provide support for internal and external audits.
• Other duties, consistent with the position, as assigned.

Requirements

• A bachelor’s degree, or higher, in a science field.
• Bachelor’s degree with 15+ years of experience working within cGMP-regulated manufacturing, specifically in validation-related roles in manufacturing and/or quality.
• Working knowledge of GMP regulations (21CFR Part 210/211, EU Annex 11/15, ICH Q7, and 21CFR 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 Prior experience with the use of an electronic document management system in a regulated environment.

Wisconsin pay range $125,000 — $140,000 USD Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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