居住国家 美国
居住城市 Irvine, California
功能区域 Operations
工作组 Engineering
雇佣类型 长期合约
工作时间 全职
居住国家 美国
居住城市 Irvine, California
功能区域 Operations
工作组 Engineering
雇佣类型 长期合约
工作时间 全职
你的角色
The Engineering Manager will have a vast understanding of engineering, engineering management, manufacturing, quality assurance, product design and process development in pharmaceutical and medical device manufacturing and will be responsible for all technical engineering tasks for execution of new product development projects, and major CAPEX Site Project approval and execution.
Interacts closely with Project Management and MS&T teams for clinical and development projects to ensure the execution of projects are performed in a timely manner and on schedule. Ensures the Process Engineers provide updates and supporting information to Project Management to ensure project status and critical information is accurate and provided in a timely manner.
Will ensure technical and engineering proficiency of new product and material technical development, product efficacy and safety validation, biocompatibility testing, preparation of IDE, IND, PMA and NDA technical sections, initiating and developing new technical and product release process.
Must have very strong technical credentials and also have the ability to manage and develop the people and functions that are part of the Engineering department. The Engineering Manager must also work closely with other departments on site initiatives for facility, equipment acquisition, site modifications, and qualifications.
Responsibilities
您的个人资料
Required Knowledge, Skills and Abilities
Required Education and Experience
在我们公司工作
我们是谁
我们在做什么Irvine
Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.
Main activities
Features
Strategic importance