Equipment Manager - GenScript/ProBio
Piscataway, NJ
About the Job
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:
This position is ideally suited for an individual with strong understanding of engineering and scientific principles and an interest in biotechnology equipment and support systems operations and optimization. Ability to work across technical disciplines and demonstrated strong post graduate learning skills is required. The selected candidate will lead and evolve the equipment calibration, maintenance, performance, and reliability function across multiple sites.
Key Responsibilities:
- Administer the computerized calibration and maintenance management system. Manage equipment inventory database which includes biotechnology processing equipment, critical analytical equipment, fixed facility assets, instrumentation, automated equipment, and control systems.
- Oversee risk-based maintenance program, equipment utilization strategy, and preventive maintenance program. Maintain equipment and component inventory and criticality list.
- Participate in Failure Mode and Effects Analyses with Vendor Engineers, Technicians, and Internal Stakeholders. Perform Root Cause Analyses and impact assessments. Investigate Out of Tolerance (OOT) events.
- Coordinate and oversee activity of third party calibration and preventive maintenance contractors for process equipment and instrumentation.
- Develop and maintain calibration specifications, tolerances, and re-calibration limits.
- Continuously optimize equipment and instrumentation reliability.
- Support Quality Control and Quality Assurance objectives.
- Training and coaching junior team members.
- Other tasks as assigned.
Qualifications
- Bachelor's degree in engineering or sciences is preferred.
- 3 to 5 years experience with biotechnology or related process equipments, instrumentation, metrology equipment and plant equipment in a laboratory or production environment.
- Familiar with the basic principle and standard of metrology
- Effective verbal and written communication skills.
- Excellent interpersonal and teamwork skills required to work effectively and efficiently in a team-based environment.
- Demonstrated successful Organizational, Planning, and Time Management skills.
- Proficiency with Microsoft products; ability to learn additional program interfaces and software applications.
- Knowledge of Statistical Process Control and ability to read and produce engineering drawing including P&ID, mechanical drawings, electronic schematics, etc. is a plus.
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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.
