GMP Metrology Specialist job opportunity at CELLARES.

Home Jobs In United States Of America Tag: Facilities & Supply Chain – Facilities GMP Metrology Specialist position at CELLARES


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CELLARES GMP Metrology Specialist
Experience: 7 Years
Pattern: On-site
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Facilities & Supply Chain,Facilities

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degreeBachelor's (B.Sc.)
loacation Bridgewater, NJ, United States Of America
loacation Bridgewater, N..........United States Of America

We are seeking an innovative and highly motivated GMP Metrology Specialist who will contribute significantly to Cellares' growth and our mission to accelerate access to life-saving cell therapies.The GMP Metrology Specialist supports the metrology program for Cellares IDMO facilities and equipment, including both new projects and existing systems. This role is responsible for the day-to-day execution of metrology activities, including oversight of vendor calibrations and preventive maintenance for process, laboratory, and facilities equipment.The GMP Metrology Specialist ensures that all facilities and equipment are properly calibrated and maintained in accordance with applicable quality standards and Good Manufacturing Practices (GMP) to support cell therapy manufacturing operations. Daily responsibilities include documentation management, adherence to established procedures, equipment scheduling, and preparation of calibration metrics and reports for the Metrology Manager.This position also ensures departmental compliance with all applicable internal policies, procedures, and external regulatory requirements.Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle various challenges as the company grows.\nResponsibilitiesSupport the facility and equipment metrology program, including owning the asset management of the Bridgewater, NJ IDMO siteProvides daily support activities such as documentation, procedure adherence, equipment scheduling, and calibration metrics reportingAssure department compliance with applicable internal and external regulatory requirements and procedures. Support internal and external auditing activitiesSupporting the development of calibration protocols, methods, and techniques based on the science of measurement, assuring accuracy and precision Ensure that laboratory equipment maintenance and calibration programs are maintained, and production operational requirements are met Support the Metrology department calibration metrics (KPIs)Provide oversight of calibration suppliers: approval, consolidation, quality, and purchasing Coordinate scheduling of vendor maintenance/calibration for GMP equipmentSupport the calibration program schedule and preventative maintenance; ensure on-time completion and review of work orders for accuracy and GMP compliance Provide technical support to operations and support personnel, maintaining equipment operationsAssist in the development of a monthly schedule for GMP clean room maintenance activitiesManage work requests/orders, including processing, generation, tracking, and follow-up; ensure work order completion, review, approval, and close-outMaintain all equipment data within a CMMSEnsure all assets are documented, maintenance plans are developed, assets are scheduled, and work orders are completeSupporting the development of calibration and equipment maintenance procedures. Author/Review/Approve documents for departmental standard operating procedures (SOPs) and programsSupporting the program leadership and team collaboration by completing all assigned projects on time and on budget, and successfully achieving expectations in compliance with our safety policies and company regulationsParticipate in developing corporate-wide systems, procedures, and tools that facilitate efficient processes throughout the organizationEnsure and support the EHS team in complying with all regulations and guidelines for a cell therapy manufacturing facilityMake critical decisions on equipment/facility issues and emergencies, effectively communicate with management, and escalate issues Create a GMP culture mindset within the metrology/engineering team supporting the cell therapy manufacturing organizationRequirements Associate’s or technical degree in an engineering-related field, or equivalent relevant work experience, required Minimum of 7 years of experience in a regulated industry, including at least 3 years of direct equipment or metrology program management experienceExperience in cell and gene therapy and/or pharmaceutical manufacturing is strongly preferredWorking knowledge of applicable governmental and regulatory requirements related to facilities and equipment, including FDA, EMA, and other relevant regulatory standardsAbility to work independently and collaboratively in a team environment, with proven ability to prioritize and manage multiple tasks while balancing competing prioritiesDemonstrated ability to adapt to shifting priorities and meet critical deadlines in a fast-paced, dynamic, and growing environmentAbility to read and interpret engineering drawings, schematics, and isometricsExcellent verbal and written communication skillsStrong organizational skills with the ability to multitask effectively and maintain attention to detailDemonstrated critical thinking and independent decision-making capabilities.Ability to handle confidential information with appropriate discretionStrong interpersonal and teamwork skills, with the ability to influence and build effective working relationships across all levels of the organizationWillingness and flexibility to take on responsibilities outside the normal scope of work as needed. Desire to contribute to a rapidly evolving organization with compelling technology and missionHigh level of self-awareness, integrity, authenticity, and a demonstrated growth mindsetProficiency in using computerized maintenance management systems (CMMS)\n$90,000 - $210,000 a year\nCellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.This is CellaresCellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.

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