Operations Engineer

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.The GMP Operations Associate I – Facilities Coordinator plays a critical role in ensuring operational excellence and compliance within Capricor’s GMP environment. This position is responsible for managing equipment calibration and preventive maintenance schedules, coordinating vendor activities, and supporting facilities operations to uphold the highest standards of quality and regulatory compliance. The ideal candidate is detail-oriented, proactive, and thrives in a fast-paced, dynamic setting where precision and collaboration are key.ResponsibilitiesMaintain and update calibration and preventive maintenance (PM) schedules for GMP-controlled equipmentSupport the induction and documentation of controlled assets in alignment with compliance requirementsCoordinate daily, weekly, and monthly facilities tasks to ensure uninterrupted operationsSchedule PM and calibration activities with external vendors and collaborate with internal teams to minimize operational impactPartner with Quality Assurance (QA) on vendor qualification and compliance verificationWork closely with Quality Engineering to ensure timely completion and closure of equipment-related work ordersCommunicate with vendors for troubleshooting and repair needs, ensuring swift resolutionAssist in managing quality records, including deviations, CAPAs, and change controls related to GMP operations and facilitiesContribute to the revision and upkeep of equipment documentation and SOPsEnsure all activities adhere to GMP regulations, internal policies, and industry best practicesRequirementsBachelor’s degree in Engineering, Life Sciences, or a related field preferred; equivalent experience consideredFamiliarity with GMP regulations and standards governing equipment and facilities operationsBasic understanding of calibration and maintenance processes for controlled equipmentStrong organizational and time-management skills with the ability to prioritize multiple tasksExcellent communication and coordination skills for effective vendor and team interactionsAbility to work independently while maintaining a collaborative approachDetail-oriented with strong problem-solving capabilitiesExperience with quality management systems or documentation processes is a plusComfortable operating in a fast-paced, highly regulated environmentWhy 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.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.