Facilities Technician V presso Vaxart

About Vaxart:

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

We are looking for a Facilities Technician V to join our South San Francisco team. This is an onsite position in our South San Francisco Office.

Summary:

This position is a Facilities Technician V role for Vaxart in South San Francisco. The Facilities Technician will provide support for Facilities operations, facility and equipment issues as well as CMMS system support. In addition, the position will support preventative maintenance and equipment repairs for both the process development and GMP groups. The position will require the individual to support documentation of repairs to facilities and equipment in line with quality and facilities procedures. The Facilities Technician V will have knowledge of facilities utilities and equipment with a focus on plumbing and electrical. The Facilities Engineer will propose and implement proactive measures to maintain and improve the Facilities equipment and utilities to meet GMP compliance and per department operating procedures. The Facilities Engineer will work with the Facility Compliance Coordinator to implement and maintain the quality and accuracy of the department’s CMMS system for schedules and asset accuracy. This role involves collaborating with cross-functional teams, managing small projects, and implementing best practices to ensure the optimal performance of our facilities.

Responsibilities:

• Assist in troubleshooting and working with lab equipment whether GMP or non-GMP, manufacturing process equipment and utilities systems.
• Coordinate and execute company work orders from the CMMS for calibrations, preventative maintenance, repairs, routine and non-routine maintenance, and proactive measures to ensure timely operation of equipment and utilities.
• Identify and respond to quality events to assure protection of product and assets.
• Analyze equipment and systems, develop corrective actions to technical problems, and carry them out.
• Performs equipment rounds and record equipment data on a log sheet.
• Monitor contractor’s performance and work closely with outside vendors to ensure work is completed according to specifications.
• Responds effectively to emergencies and support after-hours, as needed.
• Participate in project teams for major projects and complete individual projects as assigned.
• Assist in GMP equipment qualification projects.
• Understand and maintain GMP documentation for Facilities GMP equipment.
• Perform regular inspections in manufacturing and lab spaces to ensure accuracy for the CMMS with assets and spaces.
• Complies with all applicable regulations including FDA cGMP's, 21 CFR Part 11, and OSHA for the operation and maintenance of utilities and equipment and safe storage, usage, and disposal of hazardous materials.
• Maintains cleanroom equipment and utilities through best practice methods/procedures.
• Performs testing and troubleshooting of GMP equipment, components, instruments, and mechanical assemblies.
• Assist in developing methods, processes, and procedures to control, modify and improve Facilities operations.
• Other duties as assigned.

Requirements:

• Associate’s degree in an Engineering discipline, and 3 years’ directly related experience OR
• 8+years of experience in biotechnology, pharmaceutical, or other regulated industries.
• Able to work independently and have a high mechanical aptitude.
• Experience working on general construction, general repairs, HVAC, and DI water systems.
• Able to follow and align work with GMP processes and requirements.
• Ability to develop solutions to routine problems of limited scope.
• Good working knowledge of GLP-GMP facilities utilities and equipment systems.
• Able to prioritize workload and triage priority conflicts for individual work.
• Able to work independently with minimal direct supervision.
• Able to work and communicate professionally, verbally and in written form with internal and external customers.
• Experience working on teams in a collaborative cross-functional environment.
• Able to handle sensitive and confidential documents and information responsibly and with integrity.
• Knowledge of quality systems.
• Ability to perform the physical demands of the role, including but not limited to prolonged standing; ability to lift, move, and pull up to 50 pounds; kneeling; requires sitting and computer work.