Sr. Facilities Engineer

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.

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 Overview

GenScript is seeking a talented, detail oriented and self-driven individual to join the Engineering Equipment Department, contributing to the planning, design, construction, commissioning, validation, and engineering process systems development for our facilities in Piscataway, NJ. This position is valid for at least 2 years with opportunity to transition to facility manager after the construction projects are done.

Responsibilities

Project Planning and Execution: 

• Develop comprehensive project plans ensuring projects proceed according to set objectives, including requirement gathering, feasibility analysis, risk assessment, and solution formulation.
• Manage cost estimation for all project phases and create cost control plans.
• Procurement and Contract Management.
• Oversee bidding and procurement for project design, construction, and long-lead equipment.
• Manage contract signing and execution with suppliers and contractors, ensuring compliance with terms, quality, and deadlines.

Compliance and Regulatory Affairs: 

• Plan and execute government and third-party procedures to ensure project compliance with US regulations.
• Plan and manage government permits applications.

Project Management: 

• Manage technical, quality, safety, and timeline aspects of projects, ensuring timely resolution of technical issues, compliance with quality standards, and implementation of safety measures.
• Coordinate with construction firms, supervisory, and contracting units to manage internal and external project relationships.
• Commissioning and Validation:
• Organize factory acceptance tests, commissioning, and validation to ensure systems meet user requirements.

Project Completion: 

• Lead the final inspection, handover, documentation review, and project settlement activities, ensuring successful project completion and handover.
• Reporting and Improvement:
• Regularly report project progress, compile project reports, analyze lessons learned, and suggest improvements.

Qualifications and Requirements

Education and Experience: 

• Bachelor's degree or higher in Mechanical/Electrical, Chemical Engineering, Biomedical Engineering, or related fields.
• 10+ years of experience in biopharmaceuticals with substantial project management and facility operations experience.
• Hands on experience in managing construction, experience in executing projects from business requirement collection through to design, construction, commissioning, validation, and final settlement is preferred.

Skills: 

• Strong management and reporting capabilities, clear management vision, able to handle high-pressure work environments.
• Solid technical expertise combined with engineering knowledge.
• Demonstrated skills in problem solving, root cause analysis with result driven thought process.

Additional Considerations: 

• Proficient in project management software (e.g., Procore, Microsoft Project, Primavera P6).
• Familiarity with construction estimating and scheduling tools.
• Understanding of US building codes, zoning laws, safety regulations, and biopharmaceutical industry standards.

Benefits

• Competitive salary with performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Paid time off (PTO) and holidays.
• Professional development and training opportunities.

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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.