Technical Operations
Associate Engineer I, Validation
Office Location: Verona, Wisconsin, United States
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
The Associate Engineer I, Validation is an entry level position providing support for equipment, utility, analytical instrument, and facility qualification at the Arrowhead Verona site. The Associate Engineer I, Validation will coordinate and execute commissioning and qualification (C&Q) activities supporting internal GMP drug substance manufacturing and testing. This may include C&Q activities in support of new systems, modifications to existing equipment, and periodic reviews. The Associate Engineer I is responsible for ensuring internal system specifications and quality standards are applied and followed throughout the equipment lifecycle.
Responsibilities
- Creates C&Q and temperature mapping worksheets and protocols from site templates with oversight by management or senior team members.
- Advances internal and external C&Q and equipment lifecycle documentation through the review and approval process.
- Execute, or oversee vendor execution, for simple or routine qualification testing with Subject Matter Expert support. Identifies protocol events and investigates with manager support.
- Completes qualification documentation following good documentation practices.
- Prepares and reviews requirement trace matrixes and qualification reports from internal or vendor provided qualification protocols.
- Participates on project teams to report status and meet project deliverables including qualification testing, and event resolution, and closure.
- Develops ability to manage individual tasks against project schedule. Works with manager to prioritize commitments across projects.
- Participates on teams during the preparation of system design and specification documents and supports updates with oversight from team members.
- Supports completion of gap assessments for existing equipment qualifications in response to new products introduced into a manufacturing platform. Shares gaps with project team develop and execute action items.
- Supports senior team members in execution of qualification activities for systems of growing complexity, automated equipment, and systems integrated with validated computer systems.
- Responsible for completion of periodic reviews for simple equipment per assigned schedules.
- With management or team member oversight reviews simple equipment changes for impact to qualification, identifies actions needed, and completes requalification deliverables to support change completion.
- Develops an awareness of qualification best practices and looks to apply a science and risk-based approach to C&Q.
- Begins to understand qualification requirements for automated equipment and systems integrated with validated computer systems under guidance of senior team members.
- Performs other related duties as assigned.
Requirements
- Bachelor’s degree in Engineering or related scientific field
- Strong communication and documentation skills
- Proficient with Microsoft Office Suite
Preferred
- Prior experience or internship in the pharmaceutical industry, preferably with validation or quality systems.
- Prior experience with automated manufacturing equipment.
- Familiar with Blue Mountain Regulatory Asset Manager software.
- Awareness of cGMP requirements.
- Familiar with engineering drawings such as P&IDs, piping, and electrical drawings.
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.