Process Engineer (m/f/d)

at  Michael Page Switzerland

ABOUT OUR CLIENT

For our client, a leading international pharmaceutical company with modern offices in the canton of Lucerne, we are currently looking for a Process Engineer (m/f/d) within the Large Molecule Technical Operations department to support drug substance tech transfer and commercial manufacture, to start immediately for the next 12 months. Depending on the performance and motivation, the possibility of an extension is given.

JOB DESCRIPTION

The Process Engineer (m/f/d) will help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate.

Our client offers an extensive range of facilities and environments, whereas the selected candidate will have opportunities to work across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

• Works with external partners to achieve business goals and to establish a common culture
• Leads and acts as the primary interface on technical issues between technical operations and external partner drug substance manufacturers
• Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
• Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events
• Develops solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation.
• Provides on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities
• Translates understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners
• Ensures that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory
• Responsible for participation in creating, sharing, and adopting best practices and business process strategies

Please refer the Job description for details