Job Responsibilities
* 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)
* Mentoring and training of junior team members, active participation in knowledge transfer
* Participation in sampling activities or on-call duties, which may include weekend work
Minimum Requirements
* Educational background in a relevant discipline
* Work experience in the pharmaceutical or biotech industry
* Practical experience in the manufacturing of biologics under GMP, either in upstream or downstream processing or support operations
* Expert knowledge of some unit operations in upstream or downstream processing of biologics
* Prior experience with continuous manufacturing is desirable, but not required
* 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
* Business Fluent in English and German: effective oral / written communication skills in English (C1) and oral / written communication skills in German (B2)
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