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
* Set up, practical 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, 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)
Qualifications
* 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
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