<p>The Position</p> <p>This position works closely with Quality Assurance and laboratory staff to coordinate and manage Arrowhead's PMs, calibrations, and qualifications for controlled Equipment.</p> <p>This position will also be required to assist with drafting, executing, and completing qualification protocols and creating SOP and Work Instructions.</p> <p>Responsibilities</p> <ul> <li> <p>Monitor equipment - including regular testing and maintenance tasks</p> </li><li> <p>Manage and perform the internal PM/calibration schedule for equipment, including, but not limited to:</p> </li><li> <p>Synthesis and Chromatography</p> </li><li> <p>TFF and Lyophilization</p> </li><li> <p>Balances and Pipettes</p> </li><li> <p>Temperature, pressure, and flow</p> </li><li> <p>Recirculating Chillers / Temperature Control Units</p> </li><li> <p>Fridge/Freezer temperature mapping</p> </li><li> <p>Fridge/Freezer probe management</p> </li><li> <p>USP water distribution/generation skids</p> </li><li> <p>Buffer formulation and distribution</p> </li><li> <p>Chemical distribution, waste collection, and process utility systems</p> </li><li> <p>Manage and coordinate any external PM/calibration, including, but not limited to:</p> </li><li> <p>Coordinating external vendors to come onsite to perform PMs</p> </li><li> <p>Coordinating shipping of items for calibration services</p> </li><li> <p>Actively look for optimization opportunities</p> </li><li> <p>Perform, track, and maintain vendor training records</p> </li><li> <p>Troubleshoot and manage unplanned repairs to assigned equipment</p> </li><li> <p>Generate and manage a spare parts inventory</p> </li><li> <p>Coordinate and execute where applicable, all IQ/OQ/PQ activities, including drafting of Equipment Qualification Reports (EQRs)</p> </li><li> <p>Interface with regulated asset management system to track equipment statuses, document work records, and update asset records</p> </li><li> <p>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</p> </li></ul> <p>Requirements:</p> <ul> <li>Associate's degree in a related electrical, instrument maintenance, or similar field and a minimum of 8 years of experience in an electrical or mechanical troubleshooting role, 1 year of which was spent working in an Analytical GMP laboratory setting </li><li>Equivalent education and work experience will be considered (High School Diploma and a minimum of 11 years of experience, 1 year of which was spent working in an Analytical GMP laboratory setting) </li><li>Must be proficient with reading and understanding engineering drawings </li><li>Knowledgeable and experienced with LOTO (lock out tag out) </li><li>Experience with controlled documentation (SOP/WI) </li><li>Experience following change control practices for equipment and computer systems </li><li>Proficient in Microsoft Office Word, Excel, PowerPoint, and similar software </li><li>Excellent technical writing skills with high attention to detail </li><li>Good verbal and written communication skills </li><li>Follow written procedures and work instructions with attention to detail </li><li>Adhere to laboratory safety policies and procedures </li><li>Good collaboration skills with the ability to work across departments </li></ul> <p>Preferred:</p> <ul> <li>Experience with replacement or repair of diaphram pumps and process valves </li><li>Calibration experience with conductivity, pressure, flow, level indicators, temperature, mass, time, balances, chromatography, rotational and general lab equipment </li><li>Experience working on and troubleshooting electrical & mechanical equipment and automated systems </li><li>Experience working with Blue Mountain Regulatory Asset Management System </li><li>Experience with safe work permits including hot work, line breaks, and working in electrically classified areas </li></ul>