Operations Engineer II/III
Listed on 2026-02-16
-
Manufacturing / Production
Quality Engineering, Manufacturing 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 Stealth
X™ 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 Engineer plays a critical role in ensuring operational excellence and compliance within Capricor’s GMP environment. This position is responsible for executing equipment validation protocols, 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.
RESPONSIBILITIES- Execution of equipment validation protocols in coordination with our Quality Engineering team
- Maintain and update calibration and preventive maintenance (PM) schedules for GMP-controlled equipment.
- Support the induction and documentation of controlled assets in alignment with compliance requirements.
- Coordinate daily, weekly, and monthly facilities tasks to ensure uninterrupted operations.
- Schedule PM and calibration activities with external vendors and collaborate with internal teams to minimize operational impact.
- Partner with Quality Assurance (QA) on vendor qualification and compliance verification.
- Work closely with Quality Engineering to ensure timely completion and closure of equipment-related work orders.
- Communicate with vendors for troubleshooting and repair needs, ensuring swift resolution.
- Assist in managing quality records, including deviations, CAPAs, and change controls related to GMP operations and facilities.
- Contribute to the revision and upkeep of equipment documentation and SOPs.
- Ensure all activities adhere to GMP regulations, internal policies, and industry best practices.
- Bachelor’s degree in Engineering, Life Sciences, or a related field preferred; equivalent experience considered.
- Familiarity with GMP regulations and standards governing equipment and facilities operations.
- Basic understanding of calibration and maintenance processes for controlled equipment.
- Strong organizational and time-management skills with the ability to prioritize multiple tasks.
- Excellent communication and coordination skills for effective vendor and team interactions.
- Ability to work independently while maintaining a collaborative approach.
- Detail-oriented with strong problem-solving capabilities.
- Experience with quality management systems or documentation processes is a plus.
- Comfortable operating in a fast-paced, highly regulated environment.
$75,000 - $87,500 a year
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 Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.
Notice to Recruiting AgenciesCapricor 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.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).