EHS & 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:

We are seeking an EHS and Equipment Specialist. This role 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 EHS team members, support the Quality Assurance Function, and assist Facilities Services team with EHS equipment and non-EHS laboratory equipment, 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. Equipment Cleaning Safety: Use of Acids, Bases, Solvents, Vapors, and Special Gases used to clean and decontaminate equipment, on routine basis
2. Electrical Safety and Contractor Safety Oversight
3. Hazardous Energy Control and Robotic/Automated Operations Safety
4. Fume Hood and Biological Safety Cabinet operation and certification
5. HEPA filter and Non-HEPA filter testing, performance monitoring, and maintenance
6. Workplace Environmental and Occupational Health Monitoring
7. PPE selection and fitting processes: Biological and Chemical Safety
8. Proactive Risk Assessment and Risk Modeling
9. Assist compliance with Federal, State, Local, and Industry Regulations, Standards, and Codes; and assure compliance with company EHS policy and standard operating procedures.

Secondary Responsibilities: 

1. General Equipment Oversight – EHS and Non-EHS: 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 and providers of waste management vendors (including RMW); all on as-needed basis.
5. Support Quality Control and Quality Assurance objectives.

Service Support Responsibilities: 

1. Oversee selection of contractors and vendors who perform actual calibration and PM services.
2. 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.
3. Manage Haz Mat inventory, Haz Mat usage, and facility waste streams in accordance with company policy, OSHA, and related applicable regulatory requirements and industry practices.
4. File required regulatory reports.
5. Responsible for oversight of the monitoring, alarm, and alert systems for critical systems, equipment, freezers,