Plant Operations
Associate Engineer, Process Engineering
Office Location: Verona, WI
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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
As an Associate Engineer, Process Engineering, you will play a critical role in our process engineering operations and contribute to continuous improvements to enhance efficiency, safety, and productivity. You will be responsible for promoting the smooth and efficient operation of our manufacturing processes. Core duties will include overseeing implementing process/safety improvements, providing support to the processing team, and equipment management.
Responsibilities
- Identify areas for process optimization, efficiency enhancement, and cost reduction. Analyze experimental data, identify trends, and make data-driven recommendations for process enhancements
- Collaborate with cross-functional teams to translate experimental findings into actionable process improvements
- Design and perform experiments in collaboration with your supervisor to optimize existing processes or develop new ones
- Participate in process risk assessments and recommend mitigation strategies
- Safety
- Participate in hazard and operability (HAZOP) studies and process safety assessments
- Collaborate with manufacturing and safety teams to identify safety improvements
- Maintain safety systems to ensure the process remains in a ready state and future safety issues can be prevented
- Foster a culture of safety awareness and compliance throughout the production team
- Process Support
- Act as point of contact for processes associated with production of oligonucleotide drugs; this includes but is not limited to solid-phase synthesis, traditional small-molecule chemistry, chromatography, tangential flow filtration, and lyophilization
- Provide technical support for production operations, identify and resolve manufacturing issues
- Equipment Management
- Support equipment and process qualification activities and ensure compliance with regulatory requirements
- Facilitate troubleshooting and repair of equipment internally when feasible.
- Manage spare part inventory
- Document repair and spare parts activities in BMRAM.
- Documentation Management
- Aid in managing the lifecycle of equipment documentation for production equipment; this includes but is not limited to P&IDs, Design Documentation, Validation Documentation, and Equipment Qualification Records (EQRs)
- Review and update P&IDs for production processes, including equipment, instrumentation, and piping systems
- Follow P&ID change management processes, including version control and documentation updates
- Reference and aid in managing the design and validation documentation for equipment to ensure compliance and design intent are maintained
- Additional Duties as required:
- Help develop batch records in a GMP environment
- Occasionally assist with production work as needed
Requirements:
- Bachelor’s degree in Chemical Engineering, or a related field
- Minimum two years’ experience in process engineering or a similar role within a manufacturing environment
- Proficient in data analysis tools and software
- Excellent problem-solving skills and the ability to apply analytical thinking to identify and resolve process-related issues
- Strong communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams
- Good verbal and written communication skills
- Excellent technical writing skills with high attention to detail
Preferred:
- Advanced Engineering Degree
- Experience working in a GMP setting with controlled documentation
- Strong knowledge of safety regulations, process optimization methodologies, and experimental design
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.