Process Engineer (m/f/d)

Process Engineer (M/F/D)

Tasks:

• 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

Qualification:

• Educational background in a relevant discipline (bachelor´s or master´s degree)

• 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

• Experience with quality management and compliance systems (Trackwise/ SAP QM/ VeevaVault)

• Preferred Skills:

  • 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

  • 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.

Requirements: 

Start: 01.04.2025

Duration: 12 months

Capacity: 5 days per week

Location: Werthenstein, Switzerland