Technician, Metrology

Precigen Inc
  • Germantown, MD
    5 days ago

    Job Description

    Precigen is a dedicated commercial and clinical stage biopharmaceutical company advancing the next generation of gene therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Precigen has developed novel manufacturing processes to deliver UltraCAR-T and AdenoVerse immunotherapies to patients.

    The primary role of Technician, Metrology is to perform on-site calibrations and preventative maintenance within a GMP-regulated pharmaceutical manufacturing facility.

    ROLES AND RESPONSIBILITIES:

    • Perform routine in-house calibrations and preventative maintenance with GMP documentation in the CMMS.
    • Adhere to established procedures to calibrate, verify, and adjust GMP assets such as scales, gauges, controlled temperature units, and other specialized assets against known reference standards.
    • Record calibration results, identifying deviations from standards, and documenting findings in detailed reports within the quality management system.
    • Maintain calibration and preventative maintenance monthly schedules within the CMMS and schedule / escort outside vendors that perform work onsite.
    • Generate quotes and purchase orders for vendor calibrations, repairs, or preventive maintenance and identify new asset tolerances and specifications.
    • Identify and resolve issues affecting asset accuracy, including potential malfunctions or environmental factors.
    • Work closely with facilities and engineering technicians to install, modify, and / or repair GMP assets.
    • Comply with quality systems, such as Change Controls, Deviations, Corrective and Preventive Actions (CAPAs) and Audit activities, especially as they relate to metrology duties.
    • Maintain a safe work environment; work in a safe manner following all safety SOPs and wear Personal Protective Equipment (PPE) as required.

    EDUCATION AND EXPERIENCE:

    • High School Diploma or General Educational Development (GED).
    • 2+ years of Metrology experience.
    • Experience working in a GMP environment.
    • Calibration or Metrology certification preferred.
    • Experience working with Blue Mountain (CMMS), ElPro Monitor (EMS), Veeva Quality Management System, and Desigo Building Automation (BMS).

    DESIRED KEY COMPETENCIES:

    • Self-organizer, highly motivated, and keen attention to detail.
    • Excellent interpersonal, verbal, and written communication skills.
    • Ability to understand and execute the company's mission and values.
    • Maintain a high degree of ethical standard and trustworthiness.
    • Exhibits an open mindset when approaching challenges and conflict.
    • Ability to think and adapt to a rapidly changing environment and demands.
    • Strong time management and organizational skills. Ability to manage multiple projects in a fast-paced environment.

    Occasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs.

    EOE MFDV

    Numbers & Facts

    LocationGermantown, MD

    Skills

    • Autoimmune Diseaseunmatched
    • Calibrationunmatched
    • Change Controlunmatched
    • Communication Skillsunmatched
    • Computerized Maintenance Management System (CMMS)unmatched
    • Corrective Actionunmatched
    • Detail Orientedunmatched
    • Diseaseunmatched
    • Documentationunmatched
    • Drug Manufacturingunmatched
    • Facilities Engineeringunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • High School Diplomaunmatched
    • Home Automationunmatched
    • Identify Issuesunmatched
    • Infectious Diseasesunmatched
    • Interpersonal Skillsunmatched
    • Manufacturing/Industrial Processesunmatched
    • Metrologyunmatched
    • Multitaskingunmatched
    • Oncologyunmatched
    • Organizational Skillsunmatched
    • Presentation/Verbal Skillsunmatched
    • Preventative Maintenanceunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Project/Program Managementunmatched
    • Purchase Ordersunmatched
    • Quality Managementunmatched
    • Safety/Work Safetyunmatched
    • Time Managementunmatched
    • Tolerance Analysisunmatched
    • Writing Skillsunmatched

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