Equipment Specialist

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 reports to the Director of Equipment Department and is ideally suited for an individual with an understanding of health, safety and environmental equipment, regulations, and practices.  The selected candidate will assist other equipment team members, support the Quality Assurance Function, operations and compliance issues. Excellent opportunity for additional learning and development.

Details: This is a full-time role based onsite in Redmond, WA. 

Primary Responsibilities: 

1. General Equipment Oversight: Assist in Administering the computerized calibration and maintenance management system. Assist management of equipment inventory database which includes environmental monitoring equipment, biotechnology processing equipment, critical analytical equipment, fixed facility assets, instrumentation, and robotic equipment.
2. Participate in risk-based maintenance program, spare parts strategy, and preventive maintenance program.
3. 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.
4. Coordinate and oversee activity of selected third-party calibration and preventive maintenance contractors for process equipment and instrumentation.
5. Support Quality Control and Quality Assurance objectives.
6. Provide equipment and technical services to support ramp up and expansion of R&D capabilities in order to ensure utility suitability and facility readiness to support operations.
7. File required regulatory reports.

Qualifications: 

• Bachelor’s degree in Mechanical Engineering or Science is preferred.
• 0-3 years experience with biotechnology process equipment, manufacture, instrumentation, and plant equipment in a laboratory or production environment.
• Effective verbal and written communication skills
• Excellent interpersonal and teamwork skills required to work effectively and efficiently in a team-based environment
• Proficiency with Microsoft products; ability to learn additional software applications.
• Ability to read engineering drawings including P&ID’s, mechanical drawings, electrical 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.