Facilities Associate II / III

Job Description

Job Description

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is  Deramiocel ( CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

We are seeking a driven and detail-oriented Facilities Associate II / III to support and lead GMP facility operations. This individual will be responsible for independently managing equipment calibration and maintenance programs, coordinating complex vendor activities, and contributing to continuous improvement initiatives across facilities and compliance systems. The ideal candidate brings hands-on GMP experience, demonstrates sound judgment in a regulated environment, and takes initiative in solving operational issues. This role is based at our headquarters in San Diego, CA.

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.

REQUIREMENTS

• High school diploma or GED required. Bachelor's degree preferred, or equivalent relevant GMP experience in lieu of a degree
• 3+ years of experience in a highly regulated facilities (GMP/ISO) 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.

Work Environment / Physical Demands:

• Must be able to sit and stand for extended periods.
• Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.

Schedule Details:

• Shift:  Monday to Friday
• Typical hours: 2:00pm to 10:00 PM (may vary based on business needs)
• Flexibility is required, and occasional weekend availability for on call duties is needed. 

Why Capricor?

Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!

At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies

Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.