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 PositionThis position works closely with Quality Assurance, Laboratory, and Manufacturing staff to complete and oversee Arrowhead's equipment maintenance and calibrations for controlled equipment. This position will follow safe work requirements including wearing appropriate PPE and following safe work practices and the safe work permit program. This position will maintain asset records and document the completion of work in Arrowhead's regulated asset management system. This position may be required to write minor equipment change controls and initiate deviations in Arrowhead's quality management system. This position will also include vendor management.
Responsibilities- With growing independence perform calibration to NIST standards and maintenance on manufacturing, analytical, and process control systems, including, but not limited to:
- Manufacturing equipment and processes.
- Analytical laboratory equipment and processes.
- Manage monthly assignments to reliably complete routine and non-routine maintenance and calibration tasks on time. Resolves roadblocks independently or with experienced team members and escalates complex issues for support.
- Have knowledge and ability to perform a growing set of routine maintenance and calibration tasks of moderate complexity, including multi-step techniques with growing independence.
- Perform non-routine maintenance with a degree of independence. Recognize unusual circumstances and communicates findings for support. Collaborate with manager and subject matter experts on problem solving and approaches to complex problems. including drafting of Equipment Qualification Reports (EQRs), and asset induction of new equipment.
- Monitor process utility performance, including regular monitoring and testing to ensure reliable performance.
- Interface with regulated asset management system to track equipment statuses, document accurate work records, update asset records, and create calibration certificates following good documentation practices.
- Support vendors who are on-site performing services, including oversight of work documentation.
- Growing knowledge in safety programs. Independently follows safe work procedures and identifies when the safe work permit process applies to new situations. Collaborate with cross-functional teams to complete a hazards assessment and the permitting process. Completes permits for approval.
- Begins to recommend new approaches or techniques to current and new practices. Makes recommendations and supports teams with continuous improvements.
- Wear all appropriate PPE for the workspace including but not limited to: safety glasses, steel toe shoes, hard hat, vest, clean space gowning, Cryo gloves, electrical safety gloves, fall protection.
Requirements- Associate or Bachelor's Degree in mechanics, electronics technology or similar field, and 4 years of experience in a laboratory/manufacturing calibration role. (Equivalent High School and work experience will be considered)
- At least 2 years of work experience with pharmaceutical laboratory/good manufacturing processes. (cGMP)
- Must have basic skills in reading and understanding engineering drawings
- Knowledgeable with LOTO (lock out tag out)
- Experience with controlled documentation (SOP/WI)
- Proficient in Microsoft Office Word, Excel, PowerPoint, and similar software
- Developing technical writing skills with high attention to detail
- Good verbal and written communication skills
- Follow written procedures and work instructions with attention to detail
- Adhere to manufacturing and laboratory safety policies and procedures
- Good collaboration skills with ability to work with department team members.
- Experience working in a cGMP environment
Preferred- Calibration experience and repair with general lab equipment
- Experience working on and troubleshooting automated systems.
- Awareness of change control practices for equipment and computer systems.
- Experience working with Blue Mountain or other Quality Management Systems, Regulatory Asset Management Systems.
- Experience with safe work permits including hot work, line breaks, and working in electrically classified areas.
- Knowledge with equipment life cycle management.
Wisconsin pay range
$65,000-$75,000 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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