|Position||GMP Facility Engineer||Release Time||2019.10.18|
We are looking for an experienced GMP facility engineer to responsible for the overall performance and monitoring of plant utility systems. Responsible for providing operational and project support for plant utility systems. The operational support will include equipment/system design review, troubleshooting and providing in-house engineering expertise to the maintenance and manufacturing staff.
The primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Process Gasses, and HVAC systems). As well as with non-GMP/plant utilities and operations (Plant Steam, Chilled Water, Electrical and Waste Treatment systems).
Responsibilities include making all system improvements in conjunction with manufacturing, process development, validation, quality assurance, and regulatory. Must be able to work in a fast paced multi-disciplinary environment. He or she need to work directly with external clients, coordinate with internal departments, fit with collaborative and competitive culture in GenScript.
• Troubleshooting, determining root cause of problems and providing optimization strategies for utility systems within a multi-product, GMP facility.
• Be the primary liaison between manufacturing and facilities clients and external engineering contractors and vendors for utility systems.
• Serves as subject matter expert of the systems to support assigned work orders and close out Quality Systems 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 operating procedures. Use appropriate business / quality systems. Peer review or approval of related engineering and validation documents.
|Requirements||• Required education: Bachelors degree in Mechanical or Chemical or biotech Engineering
• 3-8 years experience 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.