Process Engineer
We are looking for a Process Engineer for Manufacturing Operations support. The role will be based in Lucerne for a one year contract.
Associate Specialist, Manufacturing Operations in Lucerne Start Date: ASAP Duration: 1 year
As a member of the growing manufacturing team, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.
Responsibilities would primarily entail, but are not limited to, the following:
• Set up, practical execution and troubleshooting of upstream, downstream and support unit operations in continuous
manufacturing and fed-batch processes under Good Manufacturing Practices (GMP)
• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
• Management and documentation of process execution, deviations, changes and CAPAs. Partnering with Quality Assurance and other internal stakeholders during investigations and technical discussions
• Involvement in continuous improvement efforts and support for the implementation of new technologies, including non- GMP engineering runs or testing activities
• Creation and updates of SOPs and (electronic) master batch records. Technical review of various documentation related to process transfer and GMP manufacturing
• Material management using ERP systems (SAP)
• Participation in sampling activities or on-call duties, which may include weekend work (roughly 30 percent)
To be successful in this role, you will have the following: • Educational background in a relevant discipline
• A minimum of 0-2 years of work experience in the pharmaceutical or biotech industry.
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• Ability to perform under pressure in a complex GMP environment and assume responsibility. Flexible attitude when working with internal or external stakeholders to achieve ambitious targets.
• Business Fluent in English and German (B1/B2 minimum)
• Driver’s license (B) and access to a personal car to enable on-call duties
Preferred Experience and Skills:
• A bachelor’s or master’s degree in a relevant discipline
• 1-2 years of experience in a GMP environment
• Experience with quality management and compliance systems (Trackwise/SAP QM/VeevaVault)
• Familiarity with the use of automated systems in manufacturing (DeltaV) or electronic batch records (MES)
• Prior experience with process development or process scale-up is beneficial
• Ability to work efficiently as part of a team, as well as willingness to take responsibility for independent projects
