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 operation.
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) / Oral/written communication skills in German (B2).
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).
Additional Information: International environment.
In close proximity to one of the most beautiful towns in Switzerland.
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