Technical Engineer

The Position

Arrowhead is seeking an instrument maintenance technician/engineer to join the analytical team in the CMC group. The successful candidate will be primarily responsible for the maintenance and requisite qualification for Agilent and Waters HPLC and LC-MS instruments. This person will also be responsible for the maintenance and qualification (with the aid of contracted vendors as needed) for all spectroscopic and physical instrumentation utilized in the analysis of late-phase / commercial phase pharmaceutical products. The candidate will be joining a team of highly motivated and experienced pharmaceutical scientists and will contribute to the success of Arrowhead programs.

Responsibilities

• Maintain, troubleshoot and repair HPLC and LC-MS in regulated, GMP laboratory spaces
• Schedule and perform preventive maintenance activities independently or via a contracted service provider
• Document and maintain the instrument preventative maintenance logs utilizing good documentation practices
• Conduct annual calibration and GMP qualifications of instruments
• Manage instrumentation parts and supplies inventory internally
• Contact the instrument-specific vendors to schedule major repair activities of the instruments as needed
• Assist cross-functional teams with the coordination of site-wide service contracts for critical equipment
• Willingness to learn and obtain additional training on new technologies and instrumentation
• Lead the development and creation of an in-house GMP metrology program (Validation Master Plan) for equipment repair, calibration, and qualification activities

Requirements:

• BS in science or engineering with at least 5-10 years hands-on experience with HPLC or LC-MS GMP maintenance and GMP qualification
• Familiarity and hands-on experience with a variety of instrumentation such as Gas Chromatography, FTIR, UV-Vis, Karl Fisher, and balances is preferred but not required
• Demonstrated experience working within a GMP laboratory setting for the maintenance, calibration, and qualification of analytical instrumentation utilized in Analytical Development, Quality Control, and Manufacturing
• Good organizational, communication, and time management skills
• Ability to follow instrumentation user manuals and internal work instructions
• Self-motivated individual who is eager to work as part of “a team” and individually
• Ability to troubleshoot and repair equipment
• Awareness of laboratory safety