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 and laboratory staff to coordinate and manage Arrowhead's equipment calibrations, PM's, repairs, and qualifications for controlled Equipment.
This position will also be required to assist with drafting, executing, and completion of qualification protocols in addition to creating SOP and Work Instructions.
This position will also be required to assist and mentor team members with troubleshooting equipment and metrology process guidance.
2nd shift work hours are 1pm - 11:30 pm Monday - Thursday and includes a 10% shift differential.
Responsibilities- Monitor equipment - including regular testing and maintenance tasks
- Manage and perform the internal PM/calibration schedule for equipment, including, but not limited to: complex large scale manufacturing systems, complex analytical, and automated process equipment.
- Manage and coordinate any external PM/calibration, including, but not limited to:
- Coordinating external vendors to come onsite to perform PMs
- Coordinating shipping of items for calibration services
- Actively look for optimization opportunities
- Troubleshoot and manage unplanned repairs to assigned equipment
- Coordinate and execute where applicable, all IQ/OQ/PQ activities
- Interface with regulated asset management system to track equipment statuses, document work records, and update asset records.
- Wear all appropriate PPE for the workspace including but not limited to safety: glasses, steel toe shoes, hard hat, clean space gowning, respirator, electrical safety, fall protection.
Requirements- Bachelor's degree in related field and 6 years of relative experience or associates degree and 8 years of experience or High School diploma with 10 or more years of experience.
- 6 years of experience servicing complex laboratory/manufacturing equipment or automated systems
- Knowledgeable and experienced with LOTO (lock out tag out)
- Minimum of 5 years working in a GMP setting
- Experience with controlled documentation (SOP/WI)
- Proficient in Microsoft Office Word, Excel, PowerPoint, and similar software
- Excellent 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 laboratory safety policies and procedures
- Good collaboration skills with ability to work across departments
Preferred- 8 years of experience Calibration experience and repair with general lab equipment
- 8 years of experience working on and troubleshooting electrical & mechanical equipment and automated systems cGMP 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.
- Proficient reading and understanding engineering and P&ID drawings.
Wisconsin pay range
$75,000-$88,000 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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