Facilities Engineer

Location

South San Francisco, CA | United States

Job description

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 administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart has demonstrated that its proprietary tablet 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. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for a Facilities Engineer to join our growing South San Francisco team!

This position will provide escalated support for Facilities Operations, EMS System Administration, CMMS system implementation and administration, provide quality documents as it pertains to Facility GMP Equipment Functions/ Operations. The Facilities Engineer will be knowledgeable and provide support on facilities utilities including HVAC, CDA, electric, backup generator system, house gas system, clean steam, and facilities equipment. The Facilities Engineer will support implementation of the E-Maint CMMS system and administer the Vaisala View Linc systems. They will assist in GMP space qualification. The Facilities Engineer will propose measures to maintain and improve the quality documentation as it pertains to the Facilities Department to meet GMP compliance 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, asset accuracy, PM task, calibration measurement data templates, critical spare parts inventory. This role involves collaborating with cross-functional teams, managing projects, and implementing best practices to ensure the optimal performance of our facilities .

Responsibilities:

• Assist in troubleshooting and working with all facilities lab equipment, manufacturing process equipment and utilities systems.
• Responsible for setup and maintenance of new E-Maint assets and system.
• Responsible for the ownership and maintenance of View Linc system.
• Assist in GMP space qualification and equipment qualification projects.
• Understand and maintain GMP documentation for Facilities GMP spaces and equipment, CMMS, EMS View Link system.
• Assist in the tracking and submission of quality documents, event reports, deviation reports, CAPA's.
• Maintain good documentation practices for department records following procedures to document activities.
• Works closely with manufacturing and quality teams to continuously improve the quality of existing documents and services on equipment.
• Maintains documentation for Facilities lab equipment, MFG equipment including equipment assets, equipment specifications, drawing and records.
• Provide creative solutions for reviewing data and solving problems identified during maintenance, calibrations, and repairs to maintain quality compliance of facilities records.
• Perform regular inspections in manufacturing and lab spaces to ensure accuracy for the CMMS with assets and spaces.
• Execute company work orders from the CMMS for calibrations, preventative maintenance, and repairs.
• Create audit reports and make recommendations for improvement.
• Maintains cleanroom environment through best practice methods/procedures.
• Performs set-up, calibration, testing and troubleshooting of GMP and lab equipment, components, instruments, and mechanical assemblies.
• Assist in developing methods, processes, and procedures to control, modify and improve Facilities operations.
• May train others, in calibration, testing and troubleshooting of electronic and mechanical assemblies of manufacturing and lab operations.
• Other duties as assigned.

Requirements:

• Bachelor's degree in engineering or related field from an accredited college or university or equivalent experience.
• Minimum 10 years of experience in biotechnology/pharmaceutical or other regulated industries.
• · Experience writing protocols, executing, and writing reports.
• 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.

• Must have working knowledge of GXPs and GDP and quality standards.

• Good working knowledge of GLP-GMP facilities utilities and equipment systems.
• Knowledgeable and proficient in management and maintenance of equipment CMMS and building monitoring systems.
• Must be able to prioritize workload and manage priority conflicts for individual work.
• Must be able to work independently with minimal direct supervision.
• Must be able to work and communicate professionally, verbally and in written form with internal and external customers.
• Ability to develop solutions to routine problems of limited scope.
• Provides excellent customer service with a high level of organizational skills in managing multiple tasks simultaneously.
• Must be able to handle sensitive and confidential documents and information responsibly and with integrity.
• Must have strong interpersonal skills and ability to work in a team environment.
• Knowledge of quality systems and standards.
• Excellent communication and interpersonal skills, both verbal and written.
• Excellent data collection and analysis skills.
• Experience writing protocols, executing, and writing reports.
• Reads and interprets documents, as needed for job.
• Proficient in MS Office tools: Word, Excel, Power Point and Outlook.
• Ability to perform the physical demands of the role, including but not limited to prolonged standing; ability to lift move, and pull or push up to 50 lbs.; kneeling; requires sitting and computer work.

In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately $127,000.00 - $150,000.00  USD annually. The actual salary for this role will vary based on a variety of factors including education, job-related knowledge, and experience. This range does not include equity, benefits, bonuses, or other non-monetary compensation which may be included.

Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401(k) with employer matching, tuition assistance, and work-life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by

NOTICE TO RECRUITERS AND STAFFING AGENCIES: Vaxart, Inc. has an internal recruiting department. Vaxart may supplement that internal capability from time to time with assistance from temporary staffing agencies, placement services, and professional recruiters ('Agency'). Agencies are hereby specifically directed NOT to contact Vaxart employees directly to present candidates. Vaxart's recruiting team or other authorized Vaxart personnel must present ALL candidates to hiring managers.

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