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
The Associate Engineer III, Equipment Engineering, plays a critical role plant engineering operations and contributes to continuous improvements to enhance efficiency, safety, and productivity. The Equipment Engineer III is responsible for promoting the smooth and efficient operation of our manufacturing and facility support equipment. Core duties will include identifying and implementing efficiency/safety/process support improvements, providing technical support and equipment lifecycle management to the Plant Operations team, and supporting projects to transfer new equipment to manufacturing facilities.
Responsibilities
Continuous Improvements
- Identify areas for equipment safety improvements, optimization, efficiency enhancement, and cost reduction
- Analyze operational and maintenance data, identify trends, and make data-driven recommendations for equipment enhancements
- Collaborate with cross-functional teams to translate technical recommendations into actionable equipment improvements
- Participate in process risk assessments. Recommend and implement mitigation strategies
- Performing ongoing monitoring of monitoring results for purified water, critical environments, and similar systems. Identify actionable trends and appropriate corrective actions.
Safety
- Participate in hazard and operability (HAZOP) studies and process safety assessments
- Collaborate with manufacturing, maintenance, and safety teams to identify safety improvements
- Manage safety system lifecycle to ensure equipment remains in a ready state and future safety issues can be prevented
- Foster a culture of safety awareness and compliance throughout the Plant Operations team
Equipment Support
- Follow quality change management and engineering change management processes to document equipment change plans, approval, and completion
- Coordinate across Quality and Plant Operations groups (Manufacturing, Process Engineering, Automation Engineering, Facilities, Safety, and Quality Engineering) to lead change implementation for process support systems or support changes for process systems
- Act as point of contact for plant systems supporting the production of oligonucleotide drugs; this includes but is not limited to purified water, clean in place, buffer formulation, solvent distribution, liquid waste handling, and compressed air systems
- Provide technical support for Plant Operations, identify, and resolve equipment issues escalated from maintenance groups
Equipment Management
- Support equipment commissioning and qualification activities and ensure compliance with regulatory requirements
- Facilitate complex troubleshooting and repair of equipment internally when escalated from maintenance functions
- Assess replacement parts for equivalency
- 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 support systems, including equipment, instrumentation, and piping systems
- Follow drawing change management processes, including version control and documentation updates
- Act as a system administrator or super user for the engineering drawing management system to keep engineering drawings current
- Reference and aid in managing equipment design and validation documentation in the quality management system to ensure compliance and design intent are maintained
Additional Duties as required
- Help develop maintenance procedures in a GMP environment
- Communicate with Plant Operations to schedule planned shutdown of process supporting systems
Requirements:
- Bachelor’s degree in chemical or mechanical engineering, or a related field
- 4+ years experience in equipment engineering or a similar role within a manufacturing environment
- Excellent problem-solving skills and the ability to apply critical thinking to identify and resolve equipment 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:
- Minimum of two years experience in a regulated pharmaceutical, biopharmaceutical, or life science industry
- Prior experience supporting automated systems
- Familiar with specification documentation, testing, and partnering with Automation Engineering for change implementation
- Proficient in data analysis tools and software, lean manufacturing experience, or six sigma green belt certification
- Prior experience working within a with computerized maintenance management system
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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