Facilities and Operations Associate - Open Pool

Facilities And Operations Associate

The Facilities and Operations (FAO) Associate's primary role is to assist in the planning, preparation and maintenance of laboratory-based equipment used for the development and production of cGMP biological material for use in early Phase Clinical trials. Additional roles include assisting with the maintenance of laboratory spaces for cGMP manufacturing.

Essential Job Duties:

• Perform routine maintenance and inspection using Work Orders for facility equipment, ensuring proper functionality and notification of any issues promptly to minimize negative impact.
• Act as a facility escort for equipment vendors performing on-site services.
• Adhere to all Safety and Quality regulations and rules as outlined in BioMARC's quality system and CSU's biosafety procedures; document all training as required by the quality system in a manner compliant with cGMP expectations.
• Generate, review, and maintain accurate records of facility operations, preventative, and corrective maintenance activities in compliance with BioMARC's quality system.
• Work closely with cross-functional teams, including quality assurance, quality control, and manufacturing teams to optimize equipment operations and support production/testing schedules by respond to requests from equipment owners in the electronic equipment management system.

Decision Making:

• Decision-making is limited and well defined based on written procedures and training.
• Employees are expected to think critically through written instructions and make professional judgments with regard to compliance, quality and continuous improvement paradigms.
• Decisions will be made under the supervision of senior department staff.

Supervision: None

Conditions of Employment:

• Expected to work under BSL-3 conditions and may require work with CDC Select Agents and within a cGMP compliant Quality Management System.

Minimum Qualifications:

• Bachelor's degree in Engineering or a field related to the responsibilities of the assignment OR Bachelor's degree in an unrelated field plus at least 1 years of professional experience related to the assignment.
• 1 year related experience preferred.

Conditions of Employment:

• Expected to work under BSL-3 conditions and may require work with CDC Select Agents and within a cGMP compliant Quality Management System.

Application Instructions:

Please submit a cover letter outlining your specific area(s) of expertise and a resume. This is an open pool and applications will be forwarded as position(s) become available. This pool is valid through December 31, 2026. Individuals wishing to be considered beyond this date must reapply.

Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution.