The Position

This position works closely with Quality Assurance and laboratory staff to coordinate and manage Arrowhead’s PMs, calibrations, and qualifications for controlled Equipment.

This position will also be required to assist with drafting, executing, and completing qualification protocols and creating SOP and Work Instructions.

Responsibilities

• Monitor equipment – including regular testing and maintenance tasks
• Manage and perform the internal PM/calibration schedule for equipment, including, but not limited to:
  • Synthesis and Chromatography
  • TFF and Lyophilization
  • Balances and Pipettes
  • Temperature, pressure, and flow
  • Recirculating Chillers / Temperature Control Units
  • Fridge/Freezer temperature mapping
  • Fridge/Freezer probe management
  • USP water distribution/generation skids
  • Buffer formulation and distribution
  • Chemical distribution, waste collection, and process utility systems
• 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
• Perform, track, and maintain vendor training records
• Troubleshoot and manage unplanned repairs to assigned equipment
• Generate and manage a spare parts inventory
• Coordinate and execute where applicable, all IQ/OQ/PQ activities, including drafting of Equipment Qualification Reports (EQRs)
• 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, vest, clean space gowning, Cryo gloves, electrical safety gloves, fall protection

Requirements:

• 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
• 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)
• Must be proficient with reading and understanding engineering drawings
• Knowledgeable and experienced with LOTO (lock out tag out)
• Experience with controlled documentation (SOP/WI)
• Experience following change control practices for equipment and computer systems
• 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 the ability to work across departments

Preferred: 

• Experience with replacement or repair of diaphram pumps and process valves
• Calibration experience with conductivity, pressure, flow, level indicators, temperature, mass, time, balances, chromatography, rotational and general lab equipment
• Experience working on and troubleshooting electrical & mechanical equipment and automated systems
• Experience working with Blue Mountain Regulatory Asset Management System
• Experience with safe work permits including hot work, line breaks, and working in electrically classified areas