GenScript Biotech is the world leader in the biotechnology reagent service industry, as well as an open platform for pre-clinical drugs discovery and pharmaceutical development, driven by innovative technologies.
The position reports to the Facility Engineering Director, is ideally suited for a professional with good engineering knowledge, suitable for use in GMP manufacturing of a wide range of clinical trial materials, and suitable for participating in facility and cleanroom design, construction, and commissioning. There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.
- Review Equipment and System Drawings, Specifications, and Submittals for general constructability, completeness, safety, maintainability, accessibility, operability, and conformance with the applicable codes, regulations, and design intent.
- Cross-check design basis, design calculations, and materials of construction.
- Monitor construction work in the field, including conformance to safety, schedule, design, specifications, code, and quality requirements; working in conjunction with project management, design engineers, commissioning agents, vendors, and construction professionals and contractors.
- Troubleshoot, determine root cause of problems and provide optimization strategies for utility systems and equipment within a multi-product, GMP facility.
- Provide spare parts and reliability analyses for critical components, equipment, and systems.
- Be the primary liaison between manufacturing and facilities clients and external engineering contractors and vendors for utility systems.
- Serve as subject matter expert of the facilities/utilities/systems to support assigned work orders and close out facility related quality events as applicable
- Provide project team with utility system engineering design requirements and subject matter expertise. Communicate project requirements to vendors to obtain proposals for equipment and system changes.
- Train operations staff on new/revised facility/utilities operating procedures. Use appropriate business / quality systems. Peer review or approval of related engineering and validation documents.
- Required education: Bachelors degree in Mechanical, Chemical, BioMolecular Engineering or equivalent
- No prior industry experience is required. It will be a great add-on if experienced with process and/or plant utility systems, preferably in a regulated environment.
- Effective verbal and written communication skills
- Excellent interpersonal and teamwork skills required to work effectively and efficiently in a team-based environment
- Adherence to domestic and international GMP regulations
- Ability to multi-task in a dynamic environment with changing priorities
- Proficiency with Microsoft products; ability to learn additional software applications.
- Computer Aided Design related skills are a plus