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Calibration Technician II

artivabio

San Diego, California, United States Full-time Posted 3w ago
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About Artiva: We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.   For more information, visit www.artivabio.com. Position Summary  The Calibration Technician II supports calibration, verification, troubleshooting, and preventive maintenance of laboratory and GMP manufacturing equipment. This role executes routine and moderately complex calibration work, manages associated work orders and documentation, and helps maintain audit-ready equipment records in accordance with approved procedures, GMP requirements, and data integrity expectations.  Ideal candidates have 3–5 years of hands-on calibration, GMP, and Quality Management System experience and can work with increasing independence while escalating quality or technical issues appropriately.  Key Responsibilities:   Calibration & Maintenance  * Perform calibration, verification, minor troubleshooting, and preventive maintenance on GMP laboratory and manufacturing equipment, including balances, temperature-controlled units, centrifuges, and related instrumentation.  * Execute work in accordance with approved SOPs, work instructions, calibration schedules, and cleanroom gowning requirements, including Class A/B/C environments as applicable.  * Coordinate external calibration activities, including vendor shipment, purchase order support, equipment logistics, and review of vendor calibration certificates or preventive maintenance records.  * Supervise external OEMs and third-party contractors during onsite calibration events, ensuring full adherence to facility gowning and safety rules.  * Ensure measurement standards and records maintain traceability to NIST or equivalent recognized standards.  * Initiate and process out-of-tolerance investigations immediately upon identifying a measurement deviation, detailing the required technical data to assist Quality with impact assessments.  * Support quality events, CAPAs, and related corrective actions through completion.  Work Orders & Documentation (Primary Focus)  * Create, execute, review, and close out electronic work orders in site CMMS/QMS platforms such as Blue Mountain, ACE, TrackWise, or MasterControl.  * Complete calibration records, logbooks, service reports, and related GMP documentation accurately and with minimal rework.  * Maintain audit-ready equipment files with complete, legible, traceable, and contemporaneous documentation aligned with ALCOA+ principles.  * Participate in procedure optimization by actively reviewing and redlining outdated Standard Operating Procedure or calibration methods.  * Proactively identify and correct documentation gaps or errors before QA review.  Quality & Compliance (GMP Execution)  * Perform all activities in compliance with GMP requirements, site procedures, and applicable quality systems.  * Provide accurate technical data and documentation to support deviations, CAPAs, change controls, and out-of-tolerance investigations.  * Demonstrate working knowledge of regulated GMP and EU inspection-readiness expectations.  * Support internal and external audits by retrieving records, answering basic inquiries, and ensuring documentation is complete and inspection ready.  Coordination & Ownership  * Participate in on-call rotation for environmental monitoring alarms, including initial troubleshooting, escalation, and GMP documentation.  * Coordinate with Manufacturing, QC, QA, Facilities, and external vendors to schedule calibration and maintenance activities with minimal operational disruption.  * Communicate equipment status, delays, and issues clearly and timely.  * Work under general supervision while demonstrating increasing independence and ownership of assigned equipment types. Qualifications Required: * Associate or bachelor’s degree in a scientific, technical, or engineering discipline, or equivalent experience.  * 3–5 years of hands-on experience in a GMP-regulated calibration, laboratory, manufacturing, or facilities environment.  * Experience using CMMS/QMS systems to execute work orders and complete GMP documentation.  * Working knowledge of calibration principles, measurement concepts, GMP documentation practices, and ALCOA+ data integrity expectations.  Preferred  * Experience in pharmaceutical, biopharmaceutical, cell therapy, or analytical laboratory environments.  * Ability to aseptically gown and demonstrate appropriate cleanroom behavior.  * Exposure to laboratory/manufacturing equipment calibration and equipment qualification activities such as IQ/OQ/PQ.  Required Skills & Competencies  * Proficiency with Windows, Outlook, Word, and Excel.  * Strong attention to detail, documentation accuracy, and procedural discipline.  * Ability to organize work, follow SOPs, and manage priorities in a GMP environment.  * Effective communication, collaboration, and commitment to quality, compliance, and continuous improvement.  Additional Information  * Full-time, Monday–Friday position based in a GMP-regulated facility in San Diego, CA.  * On-call activities required as assigned.  * Reports to Calibration Lead.  In addition to a great culture, we offer: •    A beautiful facility  •    An entrepreneurial, highly collaborative, and innovative environment •    Comprehensive benefits, including: •    Medical, Dental, and Vision •    Group Life Insurance •    Long Term Disability (LTD) •    401(k) Retirement Plan •    Employee Assistance Program (EAP) •    Flexible Spending Account (FSA) •    Paid Time Off (PTO) •    Company paid holidays, including the year-end holiday week •    Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $70,000–$85,000 annually. Exact compensation may vary based on level, skills and experience.

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