The Validation Manager will have to ensure that all Commissioning, Qualification and Validation activities are performed and documented according to established procedures, applicable regulations, standards and industry best practices. The Validation Manager ensures compliance and correct execution of the equipment and systems validation and revalidation programs. This will also include the Commissioning/Decommissioning and Qualification of process and laboratory equipment, clean utilities, as well as the Facilities Qualification and new products technology transfer activities, if applicable.
Job Post Information* : Posted Date
7 days ago(2/13/2019 6:32 PM)
This position will be responsible for engineering optimization and expansion activities related to our biotechnology process equipment used in the manufacturing of drug substance (DS). The Process Engineer / Senior Process Engineer leads cross-functional project teams, provides engineering leadership and support for daily operations in our manufacturing process and in the delivery of investment projects at the Düsseldorf Manufacturing Facility. In this role, you will be involved throughout the project lifecycle of legacy process equipment as well as initiation, design, procurement, construction, implementation, commissioning and qualification of new process equipment. This position will report to the Head of Process Engineering. Strong cooperation is expected with our team in manufacturing, MS&T, reliability engineering, infrastructure, automation and validation.