Associate Manufacturing Operations Specialist (m/w/d)

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)
• 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

To be successful in this role, you will have the following:

• Educational background in a relevant discipline
• A minimum of 2-5 years of work experience in the pharmaceutical or biotech industry
• A minimum of 2 years of 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)
  • Oral / written communication skills in German (B2)

Preferred Experience and Skills:

• A bachelor’s or master’s degree in a relevant discipline
• 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