What are the responsibilities and job description for the Calibration Technician position at GenScript USA Inc?
About ProBio
ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing 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. GenScript 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, GenScript 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, GenScript 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.
Job requirements:
- On-site work position in Pennington, NJ.
Job Type: Full-time
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Ability to Commute:
- Piscataway, NJ 08854 (Preferred)
Work Location: In person