Calibration Technician

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

About ProBio

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.

Job Scope

• Calibration technical role is to ensure the precision and efficacy of our calibration services provided for the following departments Manufacturing, Quality, Micro, Development and Facilities instruments and equipment’s
  
  
  

Responsibilities

• Conduct In-House calibration of Bio-Reactors, Centrifuges, Clean Steam, WFI, Autoclave, Clean Room Differential pressure, Room Temperature/Humidity, Transmitters, and Pressure gauges.
• Ensure that all calibration work orders are completed accurately and follow all GDP guidelines.
• Diagnose and rectify issues with calibrated equipment and instrumentation.
• Ensure all equipment’s and instruments are calibrated within the require timelines.
• Perform other tasks as required.
  
  
  

Qualifications

• An Associate’s degree in Engineering or Technical certification in instrumentation and a minimum of 4 years of equipment calibration experience in a GMP regulated industry.
• Knowledge of cGMP, GXP, GDP, Equipment Life cycle.
• Cycle (SDLC) regulations, knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Knowledge of Computerized Maintenance Management Systems (CMMS).
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  
  
  

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GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.