Facilities Associate II / III

Capricor Therapeutics•San Diego, CA

3d•Onsite

About The Position

Capricor Therapeutics is a biotechnology company focused on developing cell and exosome-based therapies for rare diseases. Their lead therapy, Deramiocel (CAP-1002), is in late-stage development for Duchenne muscular dystrophy. They also utilize their StealthX™ exosome platform for targeted delivery and vaccinology. The company is seeking a Facilities Associate II / III to support and lead GMP facility operations. This role involves managing equipment calibration and maintenance, coordinating vendor activities, and contributing to continuous improvement in facilities and compliance systems. The ideal candidate will have hands-on GMP experience, good judgment in a regulated setting, and a proactive approach to problem-solving.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field preferred; equivalent hands-on experience in GMP environments will be considered.
3–5 years of experience in a GMP-regulated facilities or equipment maintenance role, ideally in biotech or pharmaceutical manufacturing.
Strong understanding of GMP compliance, calibration standards, and equipment lifecycle management.
Demonstrated ability to manage vendors, prioritize competing tasks, and work independently with minimal supervision.
Proficiency in equipment tracking and maintenance systems; experience with CMMS or QMS software a plus.
Excellent written and verbal communication skills for clear documentation and cross-functional collaboration.
Exceptional organizational skills and attention to detail, with a proactive and solutions-oriented mindset.

Nice To Haves

Experience with CMMS or QMS software

Responsibilities

Own and manage the calibration and preventive maintenance program for GMP-critical equipment, ensuring accuracy, compliance, and timely execution.
Lead the induction of new controlled assets into the inventory and maintenance tracking systems.
Independently execute and improve daily, weekly, and monthly facilities operations to support manufacturing and laboratory readiness.
Develop, revise, and optimize calibration and preventive maintenance schedules in alignment with operational needs and regulatory standards.
Create and maintain accurate equipment documentation, including maintenance logs, procedures, and records.
Schedule and coordinate maintenance and calibration work with external vendors and internal teams, ensuring minimal disruption to production and lab activities.
Drive vendor qualification processes in partnership with Quality Assurance, including documentation review and audit support.
Collaborate with Quality Engineering to ensure timely completion and closure of equipment work orders, deviations, and change controls.
Act as a key contact for troubleshooting and resolving equipment issues, coordinating repairs and root cause analysis with vendors.
Initiate and support quality records, including deviations, CAPAs, and change controls that impact GMP operations and facilities infrastructure.
Identify and recommend process improvements to enhance facility efficiency, compliance, and reliability.