Associate Engineer, cGMP Computer Systems Validation

Arrowhead Pharmaceuticals•Verona, WI

6h•$80,000 - $95,000

About The Position

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 Provide quality assurance support to computer system assurance (CSA) and computer system validation (CSV) within Quality Engineering (QE) to ensure compliance with company policies and procedures. Review and approve records and documentation supporting CSA and CSV activities for GxP computerized systems, including applications, cloud-based solutions, and software tools. Collaborate closely with other departments to ensure that CSA and CSV activities and data integrity initiatives for GxP computerized systems are supported.

Requirements

Bachelor's degree in science, engineering, or a related technical discipline and minimum of four (4) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry. Alternative and equivalent education and experience shall be considered.
Intermediate understanding of GxP manufacturing and/or testing.
Working knowledge of GxP regulations, including GMP (FDA, EU, etc.), 21 CFR Part 11, EU Annex 11, ICH guidelines, and/or ISO standards.
Experience maintaining QE elements and the associated systems and processes.
Motivated team player, who endeavors to resolve problems.
Strong communication and interpersonal skills, with the ability to work with a diverse range of professionals.
Ability to work independently and manage priorities within a fast-paced environment with limited oversight from leadership.

Nice To Haves

Prior experience with an electronic document management system in a regulated environment.
Competent knowledge of an ability to use Adobe Acrobat and Microsoft Office programs.

Responsibilities

Review records in the computerized maintenance management system (CMMS), or equivalent, ensuring compliance with company policies and procedures.
Review plans, protocols, protocol events, reports, and other CSA/CSV lifecycle deliverables supporting systems and processes with increasing complexity or risk.
Review and approve deviations, change controls, and corrective actions and preventive actions (CAPAs) in support of systems and processes with increasing complexity or risk.
Maintain policies and procedures related to QE elements in alignment with industry standards and corporate policies with oversight from leadership.
Participate in cross functional teams to support initiatives associated with CSA/CSV activities.
Comply with and advise on the requirements of the Quality Management System, including deviations and investigations; corrective actions and preventive actions (CAPA); and change control.
Serve as quality contact and subject matter expert (SME) for CSA/CSV activities, providing guidance and oversight for simple systems and processes.
Implement improvements to established systems, processes, procedures, etc. with oversight from leadership.
Perform additional duties as requested.